Clearance Summary
OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC received FDA 510(k) clearance under submission number K891048, sponsored by Zinnanti 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 1989-03-22.
- Submission: K891048
- Applicant / Sponsor: Zinnanti Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1989-03-22
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.