Cleared Traditional

K934356 - WILSON-COOK GI ASPIRATION NEEDLE

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

K934356 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K934356

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
9d faster than avg
Panel avg: 131d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K934356.
COAXIAL BIOPSY NEEDLE
K936194 · Bard Gynecology and Radiology · Mar 1994
BIP-COAX-SYSTEM
K915801 · Uni-Quatro Industries Canada, Inc. · Mar 1994
BIP BIOPSY NEEDLE MODIFICATION
K934370 · Bip USA, Inc. · Mar 1994
PROACT BIOPSY NEEDLE ENCHANCEMENTS
K926559 · Proact, Ltd. · Mar 1993
CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES
K924271 · Core Medical, Inc. · Nov 1992
CORE MEDICAL BIOPSY NEEDLE
K914732 · Core Medical, Inc. · Jan 1992
K934356 · WILSON-COOK GI ASPIRATION NEEDLE
Download PDF FDA Summary Wilson-Cook Medical, …