# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Oct 7, 2025 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K936109 (1994). 148 ancestors in all.
No later device cites it as a predicate yet.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211838: Ultrasonic Bipolar Generator USG-410 with accessories, Olympus Medical Systems Corporation (2021) Summary page 6.

## Recalls of this device
- Mar 23, 2026 · Class II · Z-1853-2026: Potential for detachment of a distal tip component of the device during use.
- Mar 23, 2026 · Class II · Z-1852-2026: Potential for detachment of a distal tip component of the device during use.
- Mar 23, 2026 · Class II · Z-1851-2026: Potential for detachment of a distal tip component of the device during use.
- Mar 23, 2026 · Class II · Z-1854-2026: Potential for detachment of a distal tip component of the device during use.

## Indications for use
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. The Reusable Cordless Transducer (TD-410) 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. The THUNDERBEAT II Shears with Ultrasonic Mode (TB2-0520FC, TB2-0525FC, TB2-0535FC, TB2-0545FC) are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect. The THUNDERBEAT II Shears with Ultrasonic Mode are indicated for general, plastic and reconstructive, gynecologic, urologic, thoracic, and other open, laparoscopic and endoscopic procedures. The THUNDERBEAT II Shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 7mm in diameter, tissue bundles and lymphatics using with the Seal & Cut mode or the Seal mode. The THUNDERBEAT II shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 3mm in diameter, tissue bundles and lymphatics using with the Ultrasonic mode.

Source page: https://510kreport.com/device/K252150
Methodology: https://510kreport.com/methodology