Manufacturer
Starmed Co., Ltd.TS-RF Generator (STS10)
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251566
- Device name
- TS-RF Generator (STS10)
- Company
- Starmed Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-05-22
- Decision date
- 2025-11-17
- Submission type
- Traditional
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- Surgery
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.
Intended Use
The TS-RF Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.
Device Description
The TS-RF Generator consists of an RF generator, cables, and components. Radiofrequency power is supplied and controlled with a maximum of 50 watts. Data Logs can be stored by connecting the USB Flash Driver with the communication terminal of the rear panel of the RF generator.
Summary parsed at:2026-06-20 17:49:28 UTC
Predicate devices
1—
—
Not ingested
K251566 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251566 as a predicate