Clearance Summary
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES received FDA 510(k) clearance under submission number K103696, sponsored by Erbe USA, 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 2011-03-22.
- Submission: K103696
- Applicant / Sponsor: Erbe USA, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2011-03-22
Classification & Regulation
This clearance is catalogued under FDA product code FEQ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.