Cleared Traditional

K142477 - Intact Advance and Intact Excision XL, Intact BLES

K142477 is an FDA 510(k) clearance for Intact Advance and Intact Excision XL, 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 103-day FDA review.

K142477 · Intact Medical Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
103d
Days
Class 2
Risk

K142477 is an FDA 510(k) clearance for the Intact Advance and Intact Excision XL, Intact BLES. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Intact Medical Corporation (Framingham, US). The FDA issued a Cleared decision on December 15, 2014 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intact Medical Corporation devices

FDA 510(k) Submission Details - K142477

510(k) Number K142477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2014
Decision Date December 15, 2014
Days to Decision 103 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
28d faster than avg
Panel avg: 131d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
JOHN J SMITH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT00720642 Completed Observational Industry-sponsored

Percutaneous Excision Trial

Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.

1170
Patients (actual)
24
Sites
Condition studied Imaged Breast Abnormalities
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Sponsor Intact Medical Corporation (industry)
Started 2006-07-01 → Primary completion 2011-06-01
Primary outcome
The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision.
Study completed - no results published. This trial concluded in 2011 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - KNW Instrument, Biopsy

All 304
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K142477.
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ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
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IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · Stryker Corporation · Sep 2014