Clearance Summary
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology received FDA 510(k) clearance under submission number K160740, sponsored by Surgical Instrument Service and Savings, 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 2016-05-06.
- Submission: K160740
- Applicant / Sponsor: Surgical Instrument Service and Savings, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-05-06
Classification & Regulation
This clearance is catalogued under FDA product code NLM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.