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Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)

K200557 Class II Traditional
Decision Date
2020-09-28
Sponsor / Applicant
Jiangsu Shenli Medical Production Co., Ltd.

Technical Specification

510(k) Submission ID K200557
Product Code PNR
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5980
Decision Date 2020-09-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) received FDA 510(k) clearance under submission number K200557, sponsored by Jiangsu Shenli Medical Production 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 2020-09-28.

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.