Clearance Summary
ENDOSCOPIC CAMERA received FDA 510(k) clearance under submission number K991416, sponsored by Genzyme Surgical Product (Genzyme Biosurgery). 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 1999-07-20.
- Submission: K991416
- Applicant / Sponsor: Genzyme Surgical Product (Genzyme Biosurgery)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1999-07-20
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.