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FDA 510(k)

Liver Access and Biopsy Sets

K-Number: K171853 · 2017-08-24

ApplicantCook Incorporated
Decision Date2017-08-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Liver Access and Biopsy Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-08-24 under 510(k) number K171853. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Liver Access and Biopsy Sets?

Liver Access and Biopsy Sets is a medical device that received FDA 510(k) clearance on 2017-08-24. The listed applicant is Cook Incorporated. The 510(k) number is K171853.

When did Liver Access and Biopsy Sets receive FDA 510(k) clearance?

Liver Access and Biopsy Sets received FDA 510(k) clearance on 2017-08-24, under 510(k) number K171853.

Who is the listed applicant for Liver Access and Biopsy Sets?

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

What is the FDA product code for Liver Access and Biopsy Sets?

The FDA product code for Liver Access and Biopsy Sets is DYB.

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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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