510(k) · Cleared
Recalled · Class II · 2025Surgical Tissue Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 20, 2012 as substantially equivalent to K050885 (Olympus Medical Systems Corporation, 2005) and 13 other predicates after a 266-day review. Its family tree reaches back 7 generations to 1994. 11 later devices descend from it. It has been recalled 10 times.
- Decided
- Jan 20, 2012
- Review
- 266 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 10
- Predicates
- 14
Its longest line of descent runs back 7 generations to K932293 (1994). 62 ancestors in all, the oldest K801623 (1980). 11 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 6 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 5 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 4 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 3 generations backK062949 Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
- 2 generations backK070165 Enseal PTC TrioSurgrx, Inc. · 2007 · Recalled
- 1 generation backK081129 Enseal…Surgrx, Inc. · 2008
- This deviceK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012
- Descendant · cites it directly · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014
- Descendant · 2 generations on · 6 of its ownK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- Descendant · 3 generations on · 4 of its ownK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- Descendant · 2 generations on · 4 of its ownK172610 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5…Olympus Medical Systems Corp. · 2018 · Recalled
- Descendant · cites it directly · 4 of its ownK172691 Ultrasonic GeneratorOlympus Medical Systems Corp. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · cites it directly9descendants
- K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016 · 2 generations on6descendants
- K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020 · 3 generations on4descendants
- K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp. · 2018 · 2 generations on4descendants
- K172691Ultrasonic GeneratorOlympus Medical Systems Corp. · 2017 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −6 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −5 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −4 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −3 | K062949 | Enseal PTC Tissue Seating Sealing Device | Surgrx, Inc. | 2006 | — |
| −2 | K070165 | Enseal PTC Trio | Surgrx, Inc. | 2007 | 1 |
| −1 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| 0 (this device) | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | — |
| +1 | K132703 | Thunderbeat | Olympus Medical Systems Corp. | 2014 | — |
| +2 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| +3 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| +2 | K172610 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm… | Olympus Medical Systems Corp. | 2018 | 3 |
| +1 | K172691 | Ultrasonic Generator | Olympus Medical Systems Corp. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (14)
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 |
|---|---|---|---|
| * | K050885 | Olympus Ultrasonic Surgical System SonosurgSummary page 2…____ ___ ___ ____ ___ ___ No. Ultrasonic Generator USG-400 Olympus Ultrasonic Surgical System K050885 Sonosurg Electrosurgical Generator ESG-400 UltraCision Harmonic Scalp… | 2005 |
| * | K002906 | Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07Summary page 2…Sonosurg Electrosurgical Generator ESG-400 UltraCision Harmonic Scalpel Generator K002906 300 System Valleylab ForceTriad Eleotrosurgical… | 2000 |
| * | K051644 | Valleylab Forcetriad Electrosurgical GeneratorSummary page 2…K002906 300 System Valleylab ForceTriad Eleotrosurgical K051644 Generator Valteylab ForceTriad Eleotrosurgical… | 2005 |
| * | K070162 | Forcetriad Electrosurgical Generator; Ligasure InstrumentsSummary page 2…K051644 Generator Valteylab ForceTriad Eleotrosurgical K0701 62 Generator EnSeal Vessel Sealing & Hemostasis… | 2007 |
| * | K043008 | Surgrx Enseal Vessel Sealing & Hemostasis SystemSummary page 2…K0701 62 Generator EnSeal Vessel Sealing & Hemostasis K043008 System (with RF-6O generator/controller) THUNDERBEAT TRANSDUCER Olympus Ultrasonic Surgical… | 2004 |
| * | K021962 | Olympus Ultrasonic Surgical SystemSummary page 2…System (with RF-6O generator/controller) THUNDERBEAT TRANSDUCER Olympus Ultrasonic Surgical System K021962 TD-TB400 01ympus Ultrasonic Surgical System K031305 TANDUERO… | 2003 |
| * | K031305 | Olympus Ultrasonic Surgical SystemSummary page 2…asonic Surgical System K021962 TD-TB400 01ympus Ultrasonic Surgical System K031305 TANDUEROlympus SONICEA Ultrasonic Sonosurg System K… | 2003 |
| * | K031523 | Olympus Ultrasonic Surgical SystemSummary page 2…K031305 TANDUEROlympus SONICEA Ultrasonic Sonosurg System K031523 TRNSDCEROlympus Ultrasonic Surgical System SONIBEA… | 2003 |
| * | K031710 | Olympus Ultrasonic Surgical SystemSummary page 2…K031523 TRNSDCEROlympus Ultrasonic Surgical System SONIBEA K031710 TD-SB400 Olympus Ultrasonic Surgical System K050885… | 2003 |
| * | K990430 | Ultracision Harmonic Scalpel Hand PieceSummary page 2…K050885 Sonosurg Ultrasonic Harmonic Scalpel Hand Piece K990430 UltraCision Harmonic Scalpel Generator K002906 _______… | 1999 |
| * | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Summary page 5…ot impact the performance of the device as demonstrated in performance testing. Instruments: When compared to the predicate electrical surgical instruments (K031 011 and K081129), the subject device THUNUERBEAT instruments has similar technological features such as the shaft length, sha… | 2003 |
| * | K051036 | Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PSummary page 6…a mechanical blade for cutting. 5/8 When compared to the predicate ultrasonic instruments (K050885 and K051036), the subject device has similar technological features such as the shaft length, shaft rotation, shaft diameter, cutting mecha… | 2005 |
| * | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Summary page 5…the performance of the device as demonstrated in performance testing. Instruments: When compared to the predicate electrical surgical instruments (K031 011 and K081129), the subject device THUNUERBEAT instruments has similar technological features such as the shaft length, shaft rotation,… | 2008 |
| * | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller…Summary page 2…nSeal PowerTip with EnSeal Universal K(081129 EnSeal Vessel Sealing & Hemostasis K(031133 System ____ 4 De… | 2003 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2025 | Class II | Z-1381-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Oct 22, 2025 | Class II | Z-1375-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Oct 22, 2025 | Class II | Z-1382-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Oct 22, 2025 | Class II | Z-1380-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Oct 22, 2025 | Class II | Z-1378-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Oct 22, 2025 | Class II | Z-1377-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Oct 22, 2025 | Class II | Z-1374-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Oct 22, 2025 | Class II | Z-1376-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Oct 22, 2025 | Class II | Z-1379-2026 | Under Investigation by firm | Firm is initiating a removal due to continued reports of adverse events. |
| Sep 27, 2013 | Class II | Z-0432-2014 | Use error | Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw. |
The 5 latest of 10 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 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 62 ancestors have a recall of any class.
- Of its descendants, K132703 (Olympus Medical Systems Corp., 2014) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K050885.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Surgical Tissue Management System is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-5B400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endloscopic surgery to cut (dissbct) or coagulate soft tissue or to ligate (seat and cut) vessels. The Surgical Tissue Management System…
Read the full statement (600 words)
The Surgical Tissue Management System is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-5B400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endloscopic surgery to cut (dissbct) or coagulate soft tissue or to ligate (seat and cut) vessels.
The Surgical Tissue Management System has three output modes, Seal & Cut (THUNOERBEAT), Seal (THUNDERBEAT) and Ultrasonic (SONICBEAT). The Seal & Cut mode provides combined HF bipolar and ultrasonic energy, the seal mode provides only HF bipolar energy and the Ultrasonic mode provides only ultrasonic energy.
This system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONIOBEAT for open, laparoscopic (including single-site surgery), and endloscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The THUNDERBEAT Transducer (TD-TB400) is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The THUNDERBEAT hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TO-TB400).
Seal & Cut mode:
The THUNDERBEAT 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 7mm in diameter.
Seal mode:
The THUNDERBEAT 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 7mm in diameter.
The THUNDERBEAT 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.
The SONIOBEAT Transducer (TD-SB400) is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT for open, laparoscopic (including single-site surgery), and endloscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The SONICBEAT is intended to be used with the Ultrasonic Generator (USG-400) and the SONIOBEAT Transducer (TD-SB4QO) 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 5mm in diameter.
The SONIOBEAT has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111202 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111202: Surgical Tissue Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111202
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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