Cleared Traditional

K962384 - COMFORT SHEATH REUSABLE MALE EXTERNAL C...

K962384 is the FDA 510(k) clearance for COMFORT SHEATH REUSABLE MALE EXTERNAL C... by Sierra Laboratories, Inc.. It is a Class 1 Gastroenterology & Urology device (product code EXJ) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K962384 · Sierra Laboratories, Inc. · Gastroenterology & Urology device
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Jul 1996
Decision
25d
Days
Class 1
Risk

K962384 is an FDA 510(k) clearance for the COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by Sierra Laboratories, Inc. (Tucson, US). The FDA issued a Cleared decision on July 15, 1996 after a review of 25 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 Sierra Laboratories, Inc. devices

Submission Details

510(k) Number K962384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date July 15, 1996
Days to Decision 25 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 8
Devices cleared under the same product code (EXJ) and FDA review panel - the closest regulatory comparables to K962384.
PROSYS SAMEC LA
K963265 · Convatec, A Division of E.R. Squibb & Sons · Oct 1996
SELF RETAINING MALE EXTERNAL URINARY CATHETER
K962900 · Hollister, Inc. · Sep 1996
PROSYS URIHESIVE SYSTEM LA
K951530 · Convatec, A Division of E.R. Squibb & Sons · May 1995
PROSYS URIHESICE SYSTEM NL
K950690 · Convatec, A Division of E.R. Squibb & Sons · Mar 1995
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
K946243 · Coloplast A/S · Feb 1995
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
K940269 · Hollister, Inc. · Jun 1994