Clearance Summary
INSTINCT ENDOSCOPIC HEMOCLIP received FDA 510(k) clearance under submission number K132809, sponsored by Wilson-Cook Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2013-10-25.
- Submission: K132809
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2013-10-25
Classification & Regulation
This clearance is catalogued under FDA product code PKL and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.