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FDA 510(k)

EZEE RETRIEVAL

K-Number: K162059 · 2016-09-29

ApplicantGenicon, Inc.
Decision Date2016-09-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EZEE RETRIEVAL is the device name listed in this FDA 510(k) record. The listed applicant is Genicon, Inc.. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K162059. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZEE RETRIEVAL?

EZEE RETRIEVAL is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Genicon, Inc.. The 510(k) number is K162059.

When did EZEE RETRIEVAL receive FDA 510(k) clearance?

EZEE RETRIEVAL received FDA 510(k) clearance on 2016-09-29, under 510(k) number K162059.

Who is the listed applicant for EZEE RETRIEVAL?

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

What is the FDA product code for EZEE RETRIEVAL?

The FDA product code for EZEE RETRIEVAL is GCJ.

Other records listing Genicon, Inc. as applicant

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.

K190168Aquas ProbesK181791SIMPLYSTRONG, SIMPLYEZEEK180836GenistrongK180579Ezee RetrievalK171752X-SURGE

Related Devices (Code: GCJ)

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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