Cleared Traditional

K902400 - WILSON-COOK RETRIEVAL & GRASPING FORCEPS

K902400 is the FDA 510(k) clearance for WILSON-COOK RETRIEVAL & GRASPING FORCEPS by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCZ) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K902400 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Aug 1990
Decision
69d
Days
Class 2
Risk

K902400 is an FDA 510(k) clearance for the WILSON-COOK RETRIEVAL & GRASPING FORCEPS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on August 7, 1990 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 K902400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date August 07, 1990
Days to Decision 69 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
61d faster than avg
Panel avg: 130d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCZ Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.
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 - OCZ Endoscopic Grasping/cutting Instrument, Non-powered

All 36
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K902400.
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS
K955051 · Olympus America, Inc. · Jan 1996
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
K950434 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
BIOSPSY FORCEPS
K920762 · Symbiosis Corp. · Aug 1992
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
K881332 · Baxter Healthcare Corp · Apr 1988
3 FRENCH FLEXIBLE BIOPSY FORCEPS
K881399 · Cook Urological, Inc. · Apr 1988
HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)
K874003 · Endovations · Dec 1987