Intact® Gen2 System

FDA 510(k) K152596 · Intact Medical Corporation

Substantially Equivalent

510(k) numberK152596

Submission

Device name
Intact® Gen2 System
Applicant
Intact Medical Corporation
Framingham, MA, US
Received
September 10, 2015
Decision date
February 15, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNW – Instrument, Biopsy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

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Questions and answers

When was Intact® Gen2 System cleared by the FDA?

Intact® Gen2 System (K152596) received a 510(k) decision of Substantially Equivalent on February 15, 2016, 158 days after the submission was received.

What is the product code of K152596?

The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.