Clearance Summary
SABRE BT BLUNT0TIP SURGICAL TROCAR received FDA 510(k) clearance under submission number K980804, sponsored by Endoscopic Concepts, Inc.. 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 1998-04-01.
- Submission: K980804
- Applicant / Sponsor: Endoscopic Concepts, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 1998-04-01
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.