Clearance Summary
ENDOSCOPIC NEEDLE DRIVER received FDA 510(k) clearance under submission number K960011, sponsored by United States Surgical, A Division of Tyco Healthc. 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 1996-02-21.
- Submission: K960011
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1996-02-21
Classification & Regulation
This clearance is catalogued under FDA product code OCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.