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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 the device name listed in this FDA 510(k) record. The listed applicant is Intact Medical Corporation. It received FDA 510(k) clearance on 2016-02-15 under 510(k) 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. The listed applicant is Intact Medical Corporation. The 510(k) number is K152596.

When did Intact® Gen2 System receive FDA 510(k) clearance?

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

Who is the listed applicant for Intact® Gen2 System?

The FDA 510(k) record lists Intact Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KNW)

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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