# K251566: TS-RF Generator (STS10)

- Pathway: 510(k) (Traditional)
- Applicant: Starmed Co., Ltd.
- Decided: Nov 17, 2025 after 179 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: 2 generations back to K013904 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122278: Baylis Medical Company Radiofrequency Perforation Generator, Baylis Medical Company, Inc. (2012) Summary page 2.

## Indications for use
The TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.

Source page: https://510kreport.com/device/K251566
Methodology: https://510kreport.com/methodology