Cleared Traditional

K941305 - WILSON-COOK VARIABLE LENGTH GI INJECTIO...

K941305 is the FDA 510(k) clearance for WILSON-COOK VARIABLE LENGTH GI INJECTIO... by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K941305 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jun 1994
Decision
77d
Days
Class 2
Risk

K941305 is an FDA 510(k) clearance for the WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 77 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 K941305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1994
Decision Date June 02, 1994
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 48
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K941305.
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
K954519 · Mill-Rose Laboratory · Dec 1995
INJECTION NEEDLE
K953338 · Boston Scientific Corp · Aug 1995
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
K950976 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
BARD ENDOSCOPIC INJECTION SYSTEM
K933815 · C.R. Bard, Inc. · Dec 1993
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
K921800 · Mill-Rose Laboratory · Feb 1993
NEEDLE
K924102 · United States Endoscopy Group, Inc. · Nov 1992