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FDA 510(k)

Cryotec

K-Number: K162051 · 2016-12-14

ApplicantReprolife, Inc.
Decision Date2016-12-14
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cryotec is the device name listed in this FDA 510(k) record. The listed applicant is Reprolife, Inc.. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K162051. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cryotec?

Cryotec is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Reprolife, Inc.. The 510(k) number is K162051.

When did Cryotec receive FDA 510(k) clearance?

Cryotec received FDA 510(k) clearance on 2016-12-14, under 510(k) number K162051.

Who is the listed applicant for Cryotec?

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

What is the FDA product code for Cryotec?

The FDA product code for Cryotec is MQK.

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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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