Cleared Traditional

K874314 - WILSON-COOK BIOPSY FORCEPS

K874314 is the FDA 510(k) clearance for WILSON-COOK BIOPSY FORCEPS by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K874314 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Dec 1987
Decision
48d
Days
Class 2
Risk

K874314 is an FDA 510(k) clearance for the WILSON-COOK BIOPSY FORCEPS. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on December 7, 1987 after a review of 48 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K874314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date December 07, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 160
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K874314.
VAN-TEC AUTO BIOPSY NEEDLE
K880098 · Van-Tec, Inc. · Mar 1988
ENTERON LIVER BIOPSY TRAY
K874062 · Endovations · Dec 1987
CAREY CAPSULE
K873996 · Wilson-Cook Medical, Inc. · Dec 1987
BARD BIOPTY BIOPSY SYSTEM
K871390 · C.R. Bard, Inc. · Jun 1987
SOFT TISSUE BIOPSY NEEDLE
K870785 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
PROSTATIC ASPIRATION BIOPSY SET
K870735 · Van-Tec, Inc. · Mar 1987