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Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)

K181426 Class II Traditional
Decision Date
2018-10-11
Sponsor / Applicant
Jiangsu Micsafe Medical Technology Co., Ltd.

Technical Specification

510(k) Submission ID K181426
Product Code PNR
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5980
Decision Date 2018-10-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) received FDA 510(k) clearance under submission number K181426, sponsored by Jiangsu Micsafe 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 2018-10-11.

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.