Cleared Traditional

K840864 - GORE-TEX CATHETER

K840864 is the FDA 510(k) clearance for GORE-TEX CATHETER by W.L. Gore & Associates, 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.

K840864 · W.L. Gore & Associates, Inc. · Gastroenterology & Urology device
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Jun 1984
Decision
95d
Days
Class 2
Risk

K840864 is an FDA 510(k) clearance for the GORE-TEX CATHETER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K840864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date June 01, 1984
Days to Decision 95 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
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 283
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K840864.
IVAC KEOFEED HYDROPHILIC FEEDING TUBE
K842589 · Y · Aug 1984
JEJUNOSTOMY SET FOR TUBE FEEDING
K841428 · Burron Medical Products, Inc. · Jul 1984
RECTAL IRRIGATION TUBE
K841289 · Hdc Corp. · Jul 1984
ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT
K840752 · E-Z-Em, Inc. · May 1984
MILLER-ABBOTT TUBE
K841033 · Inmed Corp. · Apr 1984
DEAVER T-DRAIN & CATTEL T-DRAIN
K841034 · Inmed Corp. · Apr 1984