FDA 510(k)

ENFit enteral syringes (NUTRIFIT)

K-Number: K211661 · 2022-02-28

Decision Date2022-02-28

Product CodePNR

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENFit enteral syringes (NUTRIFIT) is the device name listed in this FDA 510(k) record. The listed applicant is Pentaferte Italia S.R.L.. It received FDA 510(k) clearance on 2022-02-28 under 510(k) 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. The listed applicant is Pentaferte Italia S.R.L.. The 510(k) number is K211661.

When did ENFit enteral syringes (NUTRIFIT) receive FDA 510(k) clearance?

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

Who is the listed applicant for ENFit enteral syringes (NUTRIFIT)?

The FDA 510(k) record lists Pentaferte Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Pentaferte Italia S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: PNR)

Official Source

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