Clearance Summary
ETHICON ENDO-SURGERYOPTICAL DILATOR received FDA 510(k) clearance under submission number K093236, sponsored by Ethicon Endo-Surgery, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2009-11-10.
- Submission: K093236
- Applicant / Sponsor: Ethicon Endo-Surgery, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5365
- Decision date: 2009-11-10
Classification & Regulation
This clearance is catalogued under FDA product code KNQ and 21 CFR 876.5365, within the Gastroenterology, Urology review panel as a Class II device.