Cleared Traditional

K970465 - BOUSER'S URINAL

K970465 is an FDA 510(k) clearance for BOUSER'S URINAL, manufactured by General Polymers. The device is a Class 1 Gastroenterology & Urology device with product code EXJ cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K970465 · General Polymers · Gastroenterology & Urology device
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Dec 1997
Decision
314d
Days
Class 1
Risk

K970465 is an FDA 510(k) clearance for the BOUSER'S URINAL. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by General Polymers (Great Neck, US). The FDA issued a Cleared decision on December 18, 1997 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 General Polymers devices

FDA 510(k) Submission Details - K970465

510(k) Number K970465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1997
Decision Date December 18, 1997
Days to Decision 314 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
184d slower than avg
Panel avg: 130d · This submission: 314d
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 10
Devices cleared under the same product code (EXJ) and FDA review panel - the closest regulatory comparables to K970465.
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
CLEAR ADVANTAGE II
K945628 · Mentor Corp. · Jul 1995
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