Cleared Traditional

K970308 - MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE

K970308 is an FDA 510(k) clearance for MENTOR UROLOGY TRIPLE RIB OCCLUSION WRA..., manufactured by Mentor Urology, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FHA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K970308 · Mentor Urology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
65d
Days
Class 1
Risk

K970308 is an FDA 510(k) clearance for the MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE. Classified as Clamp, Penile (product code FHA), Class I - General Controls.

Submitted by Mentor Urology, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5160 - 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 Mentor Urology, Inc. devices

FDA 510(k) Submission Details - K970308

510(k) Number K970308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1997
Decision Date April 02, 1997
Days to Decision 65 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 131d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

FHA Device Classification - Class 1, General Controls

Product Code FHA Clamp, Penile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5160
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 - FHA Clamp, Penile

All 7
Devices cleared under the same product code (FHA) and FDA review panel - the closest regulatory comparables to K970308.
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CAP-AID (IMPROVED)
K964580 · Nebel, Inc. · Jan 1997
U-TEX
K955810 · Laborie Medical Technologies, Ltd. · Jan 1996
WILLIAMS PENILE ANESTHETIC RETAINER
K896160 · Cook Urological, Inc. · Feb 1990
DACOMED EXTERNAL MALE CONTINENCE DEVICE
K885323 · Dacomed Corp. · Feb 1989