Cleared Traditional

K060413 - INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE

K060413 is an FDA 510(k) clearance for INTACT BREAST LESION EXCISION SYSTEM AN..., 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 70-day FDA review.

K060413 · Intact Medical Corporation · Gastroenterology & Urology device
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Apr 2006
Decision
70d
Days
Class 2
Risk

K060413 is an FDA 510(k) clearance for the INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE. 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 April 27, 2006 after a review of 70 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 - K060413

510(k) Number K060413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2006
Decision Date April 27, 2006
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 131d · This submission: 70d
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 306
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