Cleared Traditional

K923136 - MALE EXTERNAL CATHETER

K923136 is an FDA 510(k) clearance for MALE EXTERNAL CATHETER, manufactured by Rochester Medical Corp.. The device is a Class 1 Gastroenterology & Urology device with product code EXJ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K923136 · Rochester Medical Corp. · Gastroenterology & Urology device
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Dec 1992
Decision
157d
Days
Class 1
Risk

K923136 is an FDA 510(k) clearance for the MALE EXTERNAL CATHETER. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by Rochester Medical Corp. (Stewartville, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 157 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.

FDA 510(k) Submission Details - K923136

510(k) Number K923136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date December 03, 1992
Days to Decision 157 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 131d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

EXJ Device Classification - Class 1, General Controls

Product Code EXJ Device, Incontinence, Urosheath Type, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXJ Device, Incontinence, Urosheath Type, Sterile

All 20
Devices cleared under the same product code (EXJ) and FDA review panel - the closest regulatory comparables to K923136.
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
K940269 · Hollister, Inc. · Jun 1994
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
K934266 · Sierra Laboratories, Inc. · Apr 1994
CONE CATH
K931156 · Sierra Laboratories, Inc. · Jul 1993
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
K924407 · Coloplast A/S · Sep 1992
SILICONE MALE EXTERNAL CATHETER
K913524 · Mentor Corp. · Oct 1991
CONDOM SEAL
K903715 · Mark Sullivan, M.D., P.C. · Jan 1991
K923136 · MALE EXTERNAL CATHETER
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