Clearance Summary
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER received FDA 510(k) clearance under submission number K070151, 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 2007-08-15.
- Submission: K070151
- 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: 2007-08-15
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.