FDA 510(k)

ENFit enteral syringe

K-Number: K161979 · 2017-03-22

ApplicantJiangyin Caina Technology Co., Ltd.

Decision Date2017-03-22

Product CodePNR

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENFit enteral syringe is a medical device manufactured by Jiangyin Caina Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-03-22 under approval number K161979. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENFit enteral syringe?

ENFit enteral syringe is a medical device that received FDA 510(k) clearance on 2017-03-22. It is manufactured by Jiangyin Caina Technology Co., Ltd.. The 510(k) number is K161979.

When was ENFit enteral syringe approved by the FDA?

ENFit enteral syringe received FDA 510(k) clearance on 2017-03-22, under approval number K161979.

What company makes ENFit enteral syringe?

ENFit enteral syringe is manufactured by Jiangyin Caina Technology Co., Ltd..

What is the FDA product code for ENFit enteral syringe?

The FDA product code for ENFit enteral syringe is PNR.

Related Devices (Code: PNR)

K160855U&U Enteral SyringeU&U Medical Technology Co, Ltd. K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)Vr Medical Technology K161963Monoject Enteral Syringe with ENFit ConnectorCovidien K161045MonojectCovidien K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)Neomed, Inc. K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.