Clearance Summary
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector received FDA 510(k) clearance under submission number K143186, sponsored by Erbe USA, 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 2014-12-18.
- Submission: K143186
- Applicant / Sponsor: Erbe USA, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2014-12-18
Classification & Regulation
This clearance is catalogued under FDA product code OCX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.