Clearance Summary
ENDOSCOPIC CLIP APPLIER received FDA 510(k) clearance under submission number K911817, sponsored by Surgitech C/O Collier, Shannon, Rill & Scott. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1991-06-11.
- Submission: K911817
- Applicant / Sponsor: Surgitech C/O Collier, Shannon, Rill & Scott
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1991-06-11
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.