510(k) · Cleared
Recalled · Class II · 2024Ultrasonic Bipolar Generator USG-410 with accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · LFL Instrument, Ultrasonic Surgical
Cleared on Aug 4, 2021 as substantially equivalent to K172691 (Olympus Medical Systems Corp., 2017) and 6 other predicates after a 51-day review. Its family tree reaches back 15 generations to 1994. 3 later devices descend from it. It has been recalled 13 times.
- Decided
- Aug 4, 2021
- Review
- 51 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 13
- Predicates
- 7
Its longest line of descent runs back 15 generations to K936109 (1994). 147 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations between
- 3 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 2 generations backK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- 1 generation backK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- This deviceK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021
- Descendant · cites it directly · 0 of its ownK254056 THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)…Olympus Medical Systems Corp. · 2026
- Descendant · cites it directly · 0 of its ownK252150 Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless…Olympus Medical Systems Corporation · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK231777 Electrosurgical Generator ESG-410 and Accessories (WA91327U…Olympus Winter & Ibe GmbH · 2023 · Recalled
Show all 15 generations
- Root · 15 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 14 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 13 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 12 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 11 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 10 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 9 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 8 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 6 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 5 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 4 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 3 generations backK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- 2 generations backK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- 1 generation backK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- This deviceK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp. · 2026 · cites it directly0descendants
- K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
- K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −14 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −13 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −12 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −11 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −10 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −9 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −8 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −6 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −5 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −4 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −3 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| −2 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| −1 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| 0 (this device) | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021 | — |
| +1 | K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT… | Olympus Medical Systems Corp. | 2026 | — |
| +1 | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer… | Olympus Medical Systems Corporation | 2025 | 4 |
| +1 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W)… | Olympus Winter & Ibe GmbH | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 14 | 0 |
| 1996 | 13 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172691 | Ultrasonic GeneratorSummary page 8…redicate Device* 510(k) No. Surgical Tissue Management System Ultrasonic Generator USG-400 (primary predicate) K172691 Electrosurgical Generator ESG-400 K141225 Active accessory THUNDERBEAT Open Extended J… | 2017 |
| * | K141225 | Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordSummary page 8…nt System Ultrasonic Generator USG-400 (primary predicate) K172691 Electrosurgical Generator ESG-400 K141225 Active accessory THUNDERBEAT Open Extended Jaw TB-0920OE K132703 THUNDERBEAT Type S 5mm, 20c… | 2014 |
| * | K132703 | ThunderbeatSummary page 8…surgical Generator ESG-400 K141225 Active accessory THUNDERBEAT Open Extended Jaw TB-0920OE K132703 THUNDERBEAT Type S 5mm, 20cm, Front-actuated Grip TB-0520FCS… | 2014 |
| * | K172610 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Summary page 8…K132703 THUNDERBEAT Type S 5mm, 20cm, Front-actuated Grip TB-0520FCS K172610 THUNDERBEAT Type S 5mm, 35cm, Front-actuated Grip TB-0535FCS THUNDERBEAT Type S 5mm, 45cm, Front-actuated Grip TB-0545FCS THUN… | 2018 |
| * | K151743 | THUNDERBEAT Open Fine JawSummary page 8…Front-actuated Grip TB-0535FCS THUNDERBEAT Type S 5mm, 45cm, Front-actuated Grip TB-0545FCS THUNDERBEAT Open Fine Jaw TB-0009OF K151743 THUNDERBEAT Open Fine Jaw Type X TB-0009OFX K192103 SONICBEAT 5mm, 45cm, Pistol Grip SB-0545PC… | 2016 |
| * | K192103 | Thunderbeat Open Fine Jaw Type X Hand InstrumentSummary page 8…B-0545FCS THUNDERBEAT Open Fine Jaw TB-0009OF K151743 THUNDERBEAT Open Fine Jaw Type X TB-0009OFX K192103 SONICBEAT 5mm, 45cm, Pistol Grip SB-0545PC SONICBEAT 5mm, 35cm, Pistol Grip SB-0535PC SONICBEAT 5mm, 45cm, Inline Grip SB-0545… | 2020 |
| * | K111202 | Surgical Tissue Management SystemSummary page 8…535PC SONICBEAT 5mm, 45cm, Inline Grip SB-0545IC SONICBEAT 5mm, 35cm, Inline Grip SB-0535IC SONICBEAT 5mm, 20cm, Inline Grip SB-0520IC K111202 SONICBEAT 5mm, 10cm, Inline Grip SB-0510IC SONICBEAT 5 mm, 45cm, Front-actuated Grip SB-0545FC SONICBEAT 5 mm, 35cm, Front-act… | 2012 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35… | 2026 | 0 |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)… | 2025 | 0 |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories… | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2024 | Class II | Z-0995-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-0996-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-0997-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-1001-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-1002-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-0993-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-0994-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-1000-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-0998-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-0999-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Nov 25, 2024 | Class II | Z-1003-2025 | Under Investigation by firm | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Sep 12, 2023 | Class II | Z-0109-2024 | Under Investigation by firm | Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery |
| Sep 12, 2023 | Class II | Z-0108-2024 | Under Investigation by firm | Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 17 of the 147 ancestors have a recall of any class.
- Of its descendants, K254056 (Olympus Medical Systems Corp., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
1. ULTRASONIC BIPOLAR GENERATOR USG-410 The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. 2. THUNDERBEAT Open Extended Jaw TB-09200E The THUNDERBEAT hand instrument is intended to be…
Read the full statement (1,292 words)
1. ULTRASONIC BIPOLAR GENERATOR USG-410
The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
2. THUNDERBEAT Open Extended Jaw TB-09200E
The THUNDERBEAT hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT hand instrument when used in combination with the Seal & Cut mode is indicated for open general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
Seal mode:
The THUNDERBEAT hand instrument when used in combination with the Seal mode is indicated for open general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
The THUNDERBEAT hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
3. THUNDERBEAT Type S Hand Instruments TB-0520FCS/TB-0535FCS/TB-0545FCS
The THUNDERBEAT Type S hand instruments are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT Type S hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc.), and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
Seal mode:
The THUNDERBEAT Type S hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc.), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
The THUNDERBEAT Type S hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
4. THUNDERBEAT Open Fine Jaw TB-00090F
The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
*1 It should be extended appropriately depending on the operation situation.
5. THUNDERBEAT Open Fine Jaw Type X TB-00090FX
The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
6. SONICBEAT SB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC, SB-0545FC, 0535FC and 0520FC
The SONICBEAT is intended to be used for open, laparoscopic (including single-site surgery), and general surgery to cut (dissect), coagulate, or grasp soft tissue or to ligate (seal and cut) vessels in gynecologic, thoracic, urologic, and endoscopic surgical procedures.
These devices have been designed to seal and cut vessels up to and including 5Smm in diameter.
The SONICBEAT has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
7. THUNDERBEAT Transducer TD-TB400
The THUNDERBEAT Transducer (TD-TB400) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
8. SONICBEAT Transducer TD-SB400
The SONICBEAT Transducer (TD-SB400) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
9. SONICBEAT Footswitch Connector MAJ-2412
This product is intended to be used to connect a SONICBEAT footswitch to an Ultrasonic Bipolar Generator and to communicate switch signals.
10. POWER CORD US 4.5m MAJ-2387
The power cord has been designed to be used for supplying power to Olympus equipment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211838: Ultrasonic Bipolar Generator USG-410 with accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211838
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026