Cleared Traditional

K840702 - SECURE W/25MM DIAM. SHEATH & ADHESIVE

K840702 is an FDA 510(k) clearance for SECURE W/25MM DIAM. SHEATH & ADHESIVE, manufactured by Warne Surgical Products, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K840702 · Warne Surgical Products, Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 1984
Decision
34d
Days
Class 2
Risk

K840702 is an FDA 510(k) clearance for the SECURE W/25MM DIAM. SHEATH & ADHESIVE. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Warne Surgical Products, Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1984 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Warne Surgical Products, Ltd. devices

FDA 510(k) Submission Details - K840702

510(k) Number K840702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1984
Decision Date March 22, 1984
Days to Decision 34 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 131d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNX Device Classification - Class 2, Special Controls

Product Code KNX Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
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 - KNX Collector, Urine, (and Accessories) For Indwelling Catheter

All 103
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K840702.
CHESEBROUGH-POND'S REUSABLE URINARY LEG
K842553 · Chesebrough-Pond'S U.S.A. Co. · Jul 1984
CYSTO-AID
K841197 · E-Z-Em, Inc. · Jul 1984
CURITY RIG FOLEY CATH TRAY
K841169 · The Kendal Co. · Jul 1984
URETHRAL CATH. TRAY W/BAG
K840292 · Corpak Co. · Mar 1984
URIHESIVE SYSTEM - IMPROVED
K834337 · Convatec, A Division of E.R. Squibb & Sons · Feb 1984
COLOPLAST BABY URINE COLLECTORS
K833570 · Coloplast A/S · Jan 1984