Gyne-Tech Instrument Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Gyne-Tech Instrument Corp. makes
Gyne-Tech Instrument Corp. makes electrosurgical generators, cryosurgical instruments, and ultrasound scanning devices, including the ESU100/250/550 electrosurgical generator models, the GT1ST cryosurgical instrument, and the Omega Ultrascan.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Electrosurgical Generator Model ESU100/250/550 Ref K914367
Regimes: 510(k) Registry: 510(k)Model GT1ST Cryosurgical Instrument Ref K922878
Regimes: 510(k) Registry: 510(k)Omega Ultrascan Ref K954911
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gyne-Tech Instrument Corp. have in the registry?
The registry currently lists 3 devices for Gyne-Tech Instrument Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gyne-Tech Instrument Corp.'s devices?
Among its 3 most recently registered devices, Gyne-Tech Instrument Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Gyne-Tech Instrument Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gyne-Tech Instrument Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gyne-Tech Instrument Corp. in the registry?
The most recently registered devices listed for Gyne-Tech Instrument Corp. include ELECTROSURGICAL GENERATOR MODEL ESU100/250/550, MODEL GT1ST CRYOSURGICAL INSTRUMENT and OMEGA ULTRASCAN.