Clearance Summary
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 received FDA 510(k) clearance under submission number K070198, 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 2007-06-13.
- Submission: K070198
- 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: 2007-06-13
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.