Clearance Summary
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) received FDA 510(k) clearance under submission number K162188, sponsored by Vr Medical Technology. 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 2016-09-22.
- Submission: K162188
- Applicant / Sponsor: Vr Medical Technology
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2016-09-22
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.