Clearance Summary
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER received FDA 510(k) clearance under submission number K970720, sponsored by Ethicon Endo-Surgery, 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 1997-06-27.
- Submission: K970720
- Applicant / Sponsor: Ethicon Endo-Surgery, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1997-06-27
Classification & Regulation
This clearance is catalogued under FDA product code OCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.