# K211838: Ultrasonic Bipolar Generator USG-410 with accessories

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Aug 4, 2021 after 51 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K936109 (1994). 147 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172691: Ultrasonic Generator, Olympus Medical Systems Corp. (2017) Summary page 8.
- K141225: Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord, Olympus Winter & Ibe GmbH (2014) Summary page 8.
- K132703: Thunderbeat, Olympus Medical Systems Corp. (2014) Summary page 8.
- K172610: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S,  THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S, Olympus Medical Systems Corp. (2018) Summary page 8.
- K151743: THUNDERBEAT Open Fine Jaw, Olympus Medical Systems Corp. (2016) Summary page 8.
- K192103: Thunderbeat Open Fine Jaw Type X Hand Instrument, Olympus Medical Systems Corp. (2020) Summary page 8.
- K111202: Surgical Tissue Management System, Olympus Medical Systems Corp. (2012) Summary page 8.

## Most influential descendants
- K254056: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) (2026), 0 descendants of its own
- K252150: Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) (2025), 0 descendants of its own
- K231777: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) (2023), 0 descendants of its own

## Recalls of this device
- Nov 25, 2024 · Class II · Z-0995-2025: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K211838
Methodology: https://510kreport.com/methodology