Clearance Summary
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO received FDA 510(k) clearance under submission number K134019, sponsored by Nxstage 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 2014-09-11.
- Submission: K134019
- Applicant / Sponsor: Nxstage Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2014-09-11
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.