Clearance Summary
AUTO SUTURE SURGIPORT SPIRAL SLEEVE received FDA 510(k) clearance under submission number K900123, 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 1990-04-04.
- Submission: K900123
- 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 876.5090
- Decision date: 1990-04-04
Classification & Regulation
This clearance is catalogued under FDA product code FBQ and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class II device.