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FDA 510(k)

ENFit Oral / Enteral Syringe

K-Number: K190502 · 2019-08-06

ApplicantJiangsu Caina Medical Co.,Ltd
Decision Date2019-08-06
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENFit Oral / Enteral Syringe is a medical device manufactured by Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2019-08-06 under approval number K190502. 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 Oral / Enteral Syringe?

ENFit Oral / Enteral Syringe is a medical device that received FDA 510(k) clearance on 2019-08-06. It is manufactured by Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K190502.

When was ENFit Oral / Enteral Syringe approved by the FDA?

ENFit Oral / Enteral Syringe received FDA 510(k) clearance on 2019-08-06, under approval number K190502.

What company makes ENFit Oral / Enteral Syringe?

ENFit Oral / Enteral Syringe is manufactured by Jiangsu Caina Medical Co.,Ltd.

What is the FDA product code for ENFit Oral / Enteral Syringe?

The FDA product code for ENFit Oral / Enteral Syringe is PNR.

Other Devices by Jiangsu Caina Medical Co.,Ltd

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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

View on FDA Database →

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

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