FDA 510(k)

Nutrisafe 2- ENFit Adaptor

K-Number: K151237 · 2016-02-09

ApplicantVygon

Decision Date2016-02-09

Product CodePIO

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Nutrisafe 2- ENFit Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is Vygon. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151237. The device is classified under product code PIO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nutrisafe 2- ENFit Adaptor?

Nutrisafe 2- ENFit Adaptor is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Vygon. The 510(k) number is K151237.

When did Nutrisafe 2- ENFit Adaptor receive FDA 510(k) clearance?

Nutrisafe 2- ENFit Adaptor received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151237.

Who is the listed applicant for Nutrisafe 2- ENFit Adaptor?

The FDA 510(k) record lists Vygon as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nutrisafe 2- ENFit Adaptor?

The FDA product code for Nutrisafe 2- ENFit Adaptor is PIO.

Other records listing Vygon 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.

K241587pilot TLS

Related Devices (Code: PIO)

K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl K233190ENFit AdaptorJiangsu Caina Medical Co.,Ltd K220165Enteral Transition AdaptorGBUK Group, Ltd.K162254Cedic Enteral ENFit Transition ConnectorsCedic S.R.L.

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.