Cleared Traditional

K000086 - WILSON-COOK REUSABLE HOT BIOPSY FORCEPS

K000086 is the FDA 510(k) clearance for WILSON-COOK REUSABLE HOT BIOPSY FORCEPS by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KGE) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K000086 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
63d
Days
Class 2
Risk

K000086 is an FDA 510(k) clearance for the WILSON-COOK REUSABLE HOT BIOPSY FORCEPS. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on March 15, 2000 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 K000086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2000
Decision Date March 15, 2000
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGE Forceps, Biopsy, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KGE Forceps, Biopsy, Electric

All 27
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K000086.
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474 · Fujifilm Medical System U.S.A., Inc. · Feb 2016
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · Olympus Medical Systems Corporation · Dec 2006
UNIPOLAR OPTICAL BIOPSY FORCEPS
K983811 · Olympus Winter & Ibe GmbH · Dec 1998
RESUABLE HOT BIOPSY FORCEPS
K972505 · United States Endoscopy Group, Inc. · Sep 1997
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K955052 · Olympus America, Inc. · Jan 1996