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FDA 510(k)

Enteral Extension Sets

K-Number: K203633 · 2021-08-19

ApplicantGBUK Group, Ltd.
Decision Date2021-08-19
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Enteral Extension Sets 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 2021-08-19 under 510(k) number K203633. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enteral Extension Sets?

Enteral Extension Sets is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is GBUK Group, Ltd.. The 510(k) number is K203633.

When did Enteral Extension Sets receive FDA 510(k) clearance?

Enteral Extension Sets received FDA 510(k) clearance on 2021-08-19, under 510(k) number K203633.

Who is the listed applicant for Enteral Extension Sets?

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 Extension Sets?

The FDA product code for Enteral Extension Sets is PIF.

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.

K220165Enteral Transition Adaptor

Related Devices (Code: PIF)

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.

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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.

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