Cleared Traditional

K923470 - DISPOSABLE HOT BIOPSY FORCEPS

K923470 is the FDA 510(k) clearance for DISPOSABLE 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 281-day FDA review.

K923470 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
281d
Days
Class 2
Risk

K923470 is an FDA 510(k) clearance for the DISPOSABLE 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 April 21, 1993 after a review of 281 days - an extended review 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: 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K923470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1992
Decision Date April 21, 1993
Days to Decision 281 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
151d slower than avg
Panel avg: 130d · This submission: 281d
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 26
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K923470.
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445 · Olympus America, Inc. · May 1995
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
K944765 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
K932266 · Symbiosis Corp. · Mar 1994
BIOPSY FORCEPS, ELECTRIC
K925361 · United States Endoscopy Group, Inc. · Mar 1993