Clearance Summary
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH received FDA 510(k) clearance under submission number K122511, sponsored by Ethicon Endo-Surgery, 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 2012-10-01.
- Submission: K122511
- Applicant / Sponsor: Ethicon Endo-Surgery, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2012-10-01
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.