Cleared Traditional

K081057 - INTACT BREAST LESION EXCISION SYSTEM WI...

K081057 is an FDA 510(k) clearance for INTACT BREAST LESION EXCISION SYSTEM WI..., manufactured by Intact Medical Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K081057 · Intact Medical Corporation · Gastroenterology & Urology device
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Jun 2008
Decision
64d
Days
Class 2
Risk

K081057 is an FDA 510(k) clearance for the INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Intact Medical Corporation (Natick, US). The FDA issued a Cleared decision on June 17, 2008 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intact Medical Corporation devices

FDA 510(k) Submission Details - K081057

510(k) Number K081057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date June 17, 2008
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 174
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