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FDA 510(k)

ENFit enteral syringes (NUTRIFIT)

K-Number: K211661 · 2022-02-28

ApplicantPentaferte Italia S.R.L.
Decision Date2022-02-28
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENFit enteral syringes (NUTRIFIT) is a medical device manufactured by Pentaferte Italia S.R.L.. It received FDA 510(k) clearance on 2022-02-28 under approval number K211661. 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 syringes (NUTRIFIT)?

ENFit enteral syringes (NUTRIFIT) is a medical device that received FDA 510(k) clearance on 2022-02-28. It is manufactured by Pentaferte Italia S.R.L.. The 510(k) number is K211661.

When was ENFit enteral syringes (NUTRIFIT) approved by the FDA?

ENFit enteral syringes (NUTRIFIT) received FDA 510(k) clearance on 2022-02-28, under approval number K211661.

What company makes ENFit enteral syringes (NUTRIFIT)?

ENFit enteral syringes (NUTRIFIT) is manufactured by Pentaferte Italia S.R.L..

What is the FDA product code for ENFit enteral syringes (NUTRIFIT)?

The FDA product code for ENFit enteral syringes (NUTRIFIT) is PNR.

Other Devices by Pentaferte Italia S.R.L.

K161141ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT K214080Pentaflush

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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