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FDA 510(k)

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT

K-Number: K161141 · 2017-03-22

ApplicantPentaferte Italia S.R.L.
Decision Date2017-03-22
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT is a medical device manufactured by Pentaferte Italia S.R.L.. It received FDA 510(k) clearance on 2017-03-22 under approval number K161141. 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 Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT?

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT is a medical device that received FDA 510(k) clearance on 2017-03-22. It is manufactured by Pentaferte Italia S.R.L.. The 510(k) number is K161141.

When was ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT approved by the FDA?

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT received FDA 510(k) clearance on 2017-03-22, under approval number K161141.

What company makes ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT?

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT is manufactured by Pentaferte Italia S.R.L..

What is the FDA product code for ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT?

The FDA product code for ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT is PNR.

Other Devices by Pentaferte Italia S.R.L.

K214080Pentaflush K211661ENFit enteral syringes (NUTRIFIT)

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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