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FDA 510(k)

Intact® Gen2 System

K-Number: K152596 · 2016-02-15

ApplicantIntact Medical Corporation
Decision Date2016-02-15
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Intact® Gen2 System is a medical device manufactured by Intact Medical Corporation. It received FDA 510(k) clearance on 2016-02-15 under approval number K152596. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intact® Gen2 System?

Intact® Gen2 System is a medical device that received FDA 510(k) clearance on 2016-02-15. It is manufactured by Intact Medical Corporation. The 510(k) number is K152596.

When was Intact® Gen2 System approved by the FDA?

Intact® Gen2 System received FDA 510(k) clearance on 2016-02-15, under approval number K152596.

What company makes Intact® Gen2 System?

Intact® Gen2 System is manufactured by Intact Medical Corporation.

What is the FDA product code for Intact® Gen2 System?

The FDA product code for Intact® Gen2 System is KNW.

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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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