Cleared Traditional

K936168 - WILSON-COOK BALLOON INFLATION DEVICE

K936168 is the FDA 510(k) clearance for WILSON-COOK BALLOON INFLATION DEVICE 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 95-day FDA review.

K936168 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
95d
Days
Class 2
Risk

K936168 is an FDA 510(k) clearance for the WILSON-COOK BALLOON INFLATION DEVICE. 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 March 28, 1994 after a review of 95 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 K936168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date March 28, 1994
Days to Decision 95 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
35d faster than avg
Panel avg: 130d · This submission: 95d
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 K936168.
FLEXIFLO GASTROSTOMY KIT
K932861 · Abbott Laboratories · Jun 1994
E-Z PEG
K921680 · Mill-Rose Laboratory · May 1994
VYGON - ENTERAL FEEDING TUBE - POLYURETHANE
K925854 · Vygon Corp. · May 1994
GASTROINTESTINAL FEEDING TUBE
K920703 · Wilson-Cook Medical, Inc. · Dec 1993
HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE
K932855 · Hollister, Inc. · Oct 1993
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · Abbott Laboratories · Oct 1993