# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jul 1, 2026 after 196 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: 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 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K254056
Methodology: https://510kreport.com/methodology