FDA 510(k)

Enteral Transition Adaptor

K-Number: K220165 · 2022-10-21

Decision Date2022-10-21

Product CodePIO

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Enteral Transition Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is GBUK Group, Ltd.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K220165. 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 Enteral Transition Adaptor?

Enteral Transition Adaptor is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is GBUK Group, Ltd.. The 510(k) number is K220165.

When did Enteral Transition Adaptor receive FDA 510(k) clearance?

Enteral Transition Adaptor received FDA 510(k) clearance on 2022-10-21, under 510(k) number K220165.

Who is the listed applicant for Enteral Transition Adaptor?

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

What is the FDA product code for Enteral Transition Adaptor?

The FDA product code for Enteral Transition Adaptor is PIO.

Other records listing GBUK Group, Ltd. 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.

K203633Enteral Extension Sets

Related Devices (Code: PIO)

K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl K233190ENFit AdaptorJiangsu Caina Medical Co.,Ltd K162254Cedic Enteral ENFit Transition ConnectorsCedic S.R.L.K151237Nutrisafe 2- ENFit AdaptorVygon

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.