Clearance Summary
NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES received FDA 510(k) clearance under submission number K913944, 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 1992-03-09.
- Submission: K913944
- 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: 1992-03-09
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.