Cleared Traditional

K834337 - URIHESIVE SYSTEM - IMPROVED

K834337 is an FDA 510(k) clearance for URIHESIVE SYSTEM - IMPROVED, manufactured by Convatec, A Division of E.R. Squibb & Sons. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K834337 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Feb 1984
Decision
60d
Days
Class 2
Risk

K834337 is an FDA 510(k) clearance for the URIHESIVE SYSTEM - IMPROVED. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 60 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.

FDA 510(k) Submission Details - K834337

510(k) Number K834337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date February 10, 1984
Days to Decision 60 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
71d faster than avg
Panel avg: 131d · This submission: 60d
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 205
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K834337.
SECURE W/30MM DIAM, SHEATH & ADHESIVE
K840703 · Warne Surgical Products, Ltd. · Mar 1984
SECURE W/35MM DIAM, SHEATH/ADHESIVE
K840704 · Warne Surgical Products, Ltd. · Mar 1984
URETHRAL CATH. TRAY W/BAG
K840292 · Corpak Co. · Mar 1984
URINARY DRAINAGE CONTAINER
K834448 · Vital Metrics, Inc. · Feb 1984
COLOPLAST BABY URINE COLLECTORS
K833570 · Coloplast A/S · Jan 1984
PLASTIC LEG BAG
K831530 · Forever-Dry, Inc. · Jan 1984
K834337 · URIHESIVE SYSTEM - IMPROVED
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