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FDA 510(k)

Monoject Enteral Syringe with ENFit Connector

K-Number: K161963 · 2016-09-01

ApplicantCovidien
Decision Date2016-09-01
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Monoject Enteral Syringe with ENFit Connector is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-09-01 under approval number K161963. 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 Monoject Enteral Syringe with ENFit Connector?

Monoject Enteral Syringe with ENFit Connector is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Covidien. The 510(k) number is K161963.

When was Monoject Enteral Syringe with ENFit Connector approved by the FDA?

Monoject Enteral Syringe with ENFit Connector received FDA 510(k) clearance on 2016-09-01, under approval number K161963.

What company makes Monoject Enteral Syringe with ENFit Connector?

Monoject Enteral Syringe with ENFit Connector is manufactured by Covidien.

What is the FDA product code for Monoject Enteral Syringe with ENFit Connector?

The FDA product code for Monoject Enteral Syringe with ENFit Connector is PNR.

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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 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 K170371DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip SyringeIntervene Group Limited

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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