Clearance Summary
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE received FDA 510(k) clearance under submission number K022686, sponsored by Lap Surgical Systems, LLC. 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 2002-11-25.
- Submission: K022686
- Applicant / Sponsor: Lap Surgical Systems, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2002-11-25
Classification & Regulation
This clearance is catalogued under FDA product code FED and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.