Clearance Summary
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 received FDA 510(k) clearance under submission number K093637, sponsored by Jms North America Corp.. 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 2010-02-09.
- Submission: K093637
- Applicant / Sponsor: Jms North America Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2010-02-09
Classification & Regulation
This clearance is catalogued under FDA product code FIE and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.