Cleared Traditional

K990231 - WILTEK HOT BIOPSY FORCEPS

K990231 is an FDA 510(k) clearance for WILTEK HOT BIOPSY FORCEPS, manufactured by Wiltek Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K990231 · Wiltek Medical, Inc. · Gastroenterology & Urology device
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Apr 1999
Decision
78d
Days
Class 2
Risk

K990231 is an FDA 510(k) clearance for the WILTEK HOT BIOPSY FORCEPS. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 13, 1999 after a review of 78 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 Wiltek Medical, Inc. devices

FDA 510(k) Submission Details - K990231

510(k) Number K990231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date April 13, 1999
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGE Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K990231.
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · Olympus Medical Systems Corporation · Dec 2006
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · Wilson-Cook Medical, Inc. · Mar 2000
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