# K151743: THUNDERBEAT Open Fine Jaw

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Feb 26, 2016 after 242 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K936109 (1994). 129 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132703: Thunderbeat, Olympus Medical Systems Corp. (2014) Summary page 6.
- K113572: Ligasure Curved, Small Jaw, Open Sealer/Divider, Covidien, Formerly Valleylab, A Division of Tyco H (2012) Summary page 6.
- K100597: Harmonic Focus Shears, Ethicon Endo-Surgery, LLC (2010) Summary page 6.

## Most influential descendants
- K192103: Thunderbeat Open Fine Jaw Type X Hand Instrument (2020), 4 descendants of its own
- K211838: Ultrasonic Bipolar Generator USG-410 with accessories (2021), 3 descendants of its own
- 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

## Indications for use
The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400). 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.

Source page: https://510kreport.com/device/K151743
Methodology: https://510kreport.com/methodology