Clearance Summary
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232 received FDA 510(k) clearance under submission number K992612, 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 1999-10-14.
- Submission: K992612
- 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: 1999-10-14
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.