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U&U Enteral Syringe

K160855 Class II Traditional
Decision Date
2016-11-22
Sponsor / Applicant
U&U Medical Technology Co, Ltd.

Technical Specification

510(k) Submission ID K160855
Product Code PNR
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5980
Decision Date 2016-11-22
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

U&U Enteral Syringe received FDA 510(k) clearance under submission number K160855, sponsored by U&U Medical Technology 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 2016-11-22.

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.