Clearance Summary
VOGLER HYSTERECTOMY FORCEPS (SMALL & LG) received FDA 510(k) clearance under submission number K810391, sponsored by Edward Weck, 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 1981-03-04.
- Submission: K810391
- Applicant / Sponsor: Edward Weck, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1981-03-04
Classification & Regulation
This clearance is catalogued under FDA product code HCZ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.