Intact Advance and Intact Excision XL, Intact BLES

FDA 510(k) K142477 · Intact Medical Corporation

Substantially Equivalent

510(k) numberK142477

Submission

Device name
Intact Advance and Intact Excision XL, Intact BLES
Applicant
Intact Medical Corporation
Framingham, MA, US
Received
September 3, 2014
Decision date
December 15, 2014
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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More from Forcyte Medical, LLC

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Questions and answers

When was Intact Advance and Intact Excision XL, Intact BLES cleared by the FDA?

Intact Advance and Intact Excision XL, Intact BLES (K142477) received a 510(k) decision of Substantially Equivalent on December 15, 2014, 103 days after the submission was received.

What is the product code of K142477?

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