Cleared Traditional

K900623 - ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONA...

K900623 is the FDA 510(k) clearance for ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONA... 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 606-day FDA review.

K900623 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Oct 1991
Decision
606d
Days
Class 2
Risk

K900623 is an FDA 510(k) clearance for the ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE 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 October 7, 1991 after a review of 606 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K900623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date October 07, 1991
Days to Decision 606 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
476d slower than avg
Panel avg: 130d · This submission: 606d
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 K900623.
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FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
K913786 · Abbott Laboratories · Nov 1991
WILSON-COOK RUSSELL GASTROSTOMY KIT
K912047 · Wilson-Cook Medical, Inc. · Sep 1991
FLEXIFLO ENTERAL FEEDING TUBE
K910382 · Abbott Laboratories · Aug 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897 · E-Z-Em, Inc. · Jul 1991