Clearance Summary
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) received FDA 510(k) clearance under submission number K090851, sponsored by Byrne Medical, 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 2009-07-02.
- Submission: K090851
- Applicant / Sponsor: Byrne Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2009-07-02
Classification & Regulation
This clearance is catalogued under FDA product code ODC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.