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FDA 510(k)

Needle's Eye Snare Retrieval Set - 54cm

K-Number: K163353 · 2017-07-11

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

Device Summary

Needle's Eye Snare Retrieval Set - 54cm is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-07-11 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K163353.

When was Needle's Eye Snare Retrieval Set - 54cm approved by the FDA?

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

What company makes Needle's Eye Snare Retrieval Set - 54cm?

Needle's Eye Snare Retrieval Set - 54cm is manufactured by Cook Incorporated.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.