Clearance Summary
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE received FDA 510(k) clearance under submission number K002352, sponsored by Jms Co., Ltd.. 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 2001-09-06.
- Submission: K002352
- Applicant / Sponsor: Jms Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2001-09-06
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.