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FDA 510(k)

Monoject

K-Number: K161045 · 2016-06-17

ApplicantCovidien
Decision Date2016-06-17
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Monoject is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-06-17 under approval number K161045. 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?

Monoject is a medical device that received FDA 510(k) clearance on 2016-06-17. It is manufactured by Covidien. The 510(k) number is K161045.

When was Monoject approved by the FDA?

Monoject received FDA 510(k) clearance on 2016-06-17, under approval number K161045.

What company makes Monoject?

Monoject is manufactured by Covidien.

What is the FDA product code for Monoject?

The FDA product code for Monoject 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 K161963Monoject Enteral Syringe with ENFit ConnectorCovidien 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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