Cleared Traditional

K885309 - WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS

K885309 is the FDA 510(k) clearance for WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ESW) cleared through the Traditional 510(k) pathway after a 408-day FDA review.

K885309 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Feb 1990
Decision
408d
Days
Class 2
Risk

K885309 is an FDA 510(k) clearance for the WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - 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 K885309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date February 09, 1990
Days to Decision 408 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
278d slower than avg
Panel avg: 130d · This submission: 408d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ESW Prosthesis, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
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.