Cleared Traditional

K770789 - URI-DRAIN COMBO KIT FOR MALE INCONTINENC

K770789 is the FDA 510(k) clearance for URI-DRAIN COMBO KIT FOR MALE INCONTINENC by Chesebrough-Pond'S U.S.A. Co.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K770789 · Chesebrough-Pond'S U.S.A. Co. · Gastroenterology & Urology device
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Oct 1977
Decision
168d
Days
Class 2
Risk

K770789 is an FDA 510(k) clearance for the URI-DRAIN COMBO KIT FOR MALE INCONTINENC. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Chesebrough-Pond'S U.S.A. Co. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1977 after a review of 168 days - an extended review 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: 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 Chesebrough-Pond'S U.S.A. Co. devices

Submission Details

510(k) Number K770789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1977
Decision Date October 18, 1977
Days to Decision 168 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
38d slower than avg
Panel avg: 130d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K770789.
ARGYLE URINE METER
K790969 · Sherwood Medical Co. · Jun 1979
BK-6021 CONDOM CATHETER HOLDER
K790174 · Fred Sammons, Inc. · Feb 1979
LEG BAG
K780878 · Abco Dealers, Inc. · Jul 1978
BAG, URINARY, DRAINAGE, 2D9013
K770762 · Travenol Laboratories, S.A. · May 1977
MEMBRANE SOURCE-EX SERIES DIALYZER CART.
K770516 · Extracorporeal Medical Specialities, Inc. · Mar 1977