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FDA 510(k)

NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE

K-Number: K151503 · 2016-04-05

ApplicantGbuk Enteral Limited
Decision Date2016-04-05
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Gbuk Enteral Limited. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K151503. 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 NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE?

NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Gbuk Enteral Limited. The 510(k) number is K151503.

When did NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE receive FDA 510(k) clearance?

NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE received FDA 510(k) clearance on 2016-04-05, under 510(k) number K151503.

Who is the listed applicant for NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE?

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

What is the FDA product code for NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE?

The FDA product code for NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE is PIF.

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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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