Cleared Traditional

K852490 - URI-CATH SYSTEM

K852490 is an FDA 510(k) clearance for URI-CATH SYSTEM, manufactured by Gesco Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K852490 · Gesco Intl., Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
146d
Days
Class 2
Risk

K852490 is an FDA 510(k) clearance for the URI-CATH SYSTEM. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 146 days - within the typical 510(k) review window.

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: 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 Gesco Intl., Inc. devices

FDA 510(k) Submission Details - K852490

510(k) Number K852490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date November 05, 1985
Days to Decision 146 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
15d slower than avg
Panel avg: 131d · This submission: 146d
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 94
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K852490.
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · Travenol Laboratories, S.A. · Apr 1986
AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
K861251 · American Medical Products, Inc. · Apr 1986
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · Coloplast A/S · Dec 1985
H-H SEXTON SCUP URINE MGMT. SYS
K853458 · Holter-Hausner Intl. · Aug 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085 · The Kendal Co. · Aug 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · C.R. Bard, Inc. · Jul 1985