Clearance Summary
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS received FDA 510(k) clearance under submission number K950499, sponsored by American Hydro-Surgical Instruments, Inc.. 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 1995-06-16.
- Submission: K950499
- Applicant / Sponsor: American Hydro-Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1995-06-16
Classification & Regulation
This clearance is catalogued under FDA product code KNF and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.