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FDA 510(k)

Entuit PEG, Entuit PEGJ

K-Number: K213356 · 2022-01-20

ApplicantWilson-Cook Medical, Inc.
Decision Date2022-01-20
Product CodePIF
Advisory CommitteeGU
DecisionUnknown

Device Summary

Entuit PEG, Entuit PEGJ is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K213356. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Entuit PEG, Entuit PEGJ?

Entuit PEG, Entuit PEGJ is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K213356.

When did Entuit PEG, Entuit PEGJ receive FDA 510(k) clearance?

Entuit PEG, Entuit PEGJ received FDA 510(k) clearance on 2022-01-20, under 510(k) number K213356.

Who is the listed applicant for Entuit PEG, Entuit PEGJ?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Entuit PEG, Entuit PEGJ?

The FDA product code for Entuit PEG, Entuit PEGJ is PIF.

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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.

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