Clearance Summary
ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 received FDA 510(k) clearance under submission number K914367, sponsored by Gyne-Tech Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1992-04-28.
- Submission: K914367
- Applicant / Sponsor: Gyne-Tech Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1992-04-28
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.