Clearance Summary
ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 received FDA 510(k) clearance under submission number K911272, 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 1991-07-02.
- Submission: K911272
- Applicant / Sponsor: Edward Weck, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1991-07-02
Classification & Regulation
This clearance is catalogued under FDA product code FHG and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.