Clearance Summary
NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps received FDA 510(k) clearance under submission number K152857, sponsored by Neomed, 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 2015-12-17.
- Submission: K152857
- Applicant / Sponsor: Neomed, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2015-12-17
Classification & Regulation
This clearance is catalogued under FDA product code PNR and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.