Clearance Summary
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE received FDA 510(k) clearance under submission number K142068, sponsored by Medovations, 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 2015-03-10.
- Submission: K142068
- Applicant / Sponsor: Medovations, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2015-03-10
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.