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FDA 510(k)

Needle's Eye Snare Retrieval Set - 54cm

K-Number: K163353 · 2017-07-11

ApplicantCook Incorporated
Decision Date2017-07-11
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Needle's Eye Snare Retrieval Set - 54cm is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K163353. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Needle's Eye Snare Retrieval Set - 54cm?

Needle's Eye Snare Retrieval Set - 54cm is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Cook Incorporated. The 510(k) number is K163353.

When did Needle's Eye Snare Retrieval Set - 54cm receive FDA 510(k) clearance?

Needle's Eye Snare Retrieval Set - 54cm received FDA 510(k) clearance on 2017-07-11, under 510(k) number K163353.

Who is the listed applicant for Needle's Eye Snare Retrieval Set - 54cm?

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 Needle's Eye Snare Retrieval Set - 54cm?

The FDA product code for Needle's Eye Snare Retrieval Set - 54cm is DXE.

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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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