Cleared Traditional

K041544 - COOK SIDEARM CORE TISSUE BIOPSY DEVICE

K041544 is an FDA 510(k) clearance for COOK SIDEARM CORE TISSUE BIOPSY DEVICE, manufactured by Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K041544 · Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
43d
Days
Class 2
Risk

K041544 is an FDA 510(k) clearance for the COOK SIDEARM CORE TISSUE BIOPSY DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on July 22, 2004 after a review of 43 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 Urological, Inc. devices

FDA 510(k) Submission Details - K041544

510(k) Number K041544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2004
Decision Date July 22, 2004
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
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
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K041544.
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
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V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
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SENORX BIOPSY DEVICE II
K040842 · Senorx, Inc. · Apr 2004
MAMMOTOME EX HAND HELD SYSTEM
K033700 · Ethicon Endo-Surgery, Inc. · Feb 2004
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K032943 · Stryker Corp. · Dec 2003