Clearance Summary
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 received FDA 510(k) clearance under submission number K051950, 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 2005-10-07.
- Submission: K051950
- Applicant / Sponsor: Ethicon Endo-Surgery, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2005-10-07
Classification & Regulation
This clearance is catalogued under FDA product code MND and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.