Clearance Summary
JMS APHERESIS NEEDLE SET WINGEATER(R) V2 received FDA 510(k) clearance under submission number K112178, sponsored by JMS North America Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2011-10-27.
- Submission: K112178
- Applicant / Sponsor: JMS North America Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2011-10-27
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.