Cleared Traditional

K934356 - WILSON-COOK GI ASPIRATION NEEDLE

K934356 is the FDA 510(k) clearance for WILSON-COOK GI ASPIRATION NEEDLE by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K934356 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jan 1994
Decision
122d
Days
Class 2
Risk

K934356 is an FDA 510(k) clearance for the WILSON-COOK GI ASPIRATION NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (West Lafayette, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 122 days - within the typical 510(k) review window.

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: 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 K934356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date January 07, 1994
Days to Decision 122 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
8d faster than avg
Panel avg: 130d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCG Biopsy Needle
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 - FCG Biopsy Needle

All 49
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K934356.
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K943304 · Olympus America, Inc. · Dec 1995
RUTNER BIOPSY DEVICE
K950810 · Cook Urological, Inc. · Mar 1995
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · C.R. Bard, Inc. · Jun 1991
MANAN PROSTATIC BIOPSY NEEDLE
K895897 · Manan Medical Products, Inc. · Oct 1989
BIOPSY NEEDLE GUIDE ATTACHMENT
K890327 · Elscint, Inc. · Mar 1989