Clearance Summary
DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM received FDA 510(k) clearance under submission number K921716, sponsored by American Surgical Instruments 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 1993-11-08.
- Submission: K921716
- Applicant / Sponsor: American Surgical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1993-11-08
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.