Cleared Traditional

K912047 - WILSON-COOK RUSSELL GASTROSTOMY KIT

K912047 is the FDA 510(k) clearance for WILSON-COOK RUSSELL GASTROSTOMY KIT by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K912047 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Sep 1991
Decision
119d
Days
Class 2
Risk

K912047 is an FDA 510(k) clearance for the WILSON-COOK RUSSELL GASTROSTOMY KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on September 5, 1991 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 K912047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1991
Decision Date September 05, 1991
Days to Decision 119 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K912047.
DOBBHOFF(R) SINGLE PASS PEG KIT
K913784 · Biosearch Medical Products, Inc. · Jan 1992
FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
K913786 · Abbott Laboratories · Nov 1991
ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE
K900623 · Wilson-Cook Medical, Inc. · Oct 1991
FLEXIFLO ENTERAL FEEDING TUBE
K910382 · Abbott Laboratories · Aug 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897 · E-Z-Em, Inc. · Jul 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332 · Abbott Laboratories · Mar 1991