Clearance Summary
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 received FDA 510(k) clearance under submission number K093718, sponsored by Zutron Medical, LLC. 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 2010-02-22.
- Submission: K093718
- Applicant / Sponsor: Zutron Medical, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-02-22
Classification & Regulation
This clearance is catalogued under FDA product code FCY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.