Cleared Traditional

K971992 - UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)

K971992 is an FDA 510(k) clearance for UROMED ALTERNATIVE BLADDER CONTROL CONT..., manufactured by Uromed Corp.. The device is a Class 1 Gastroenterology & Urology device with product code FHA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K971992 · Uromed Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
64d
Days
Class 1
Risk

K971992 is an FDA 510(k) clearance for the UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026). Classified as Clamp, Penile (product code FHA), Class I - General Controls.

Submitted by Uromed Corp. (Needham, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 64 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 Uromed Corp. devices

FDA 510(k) Submission Details - K971992

510(k) Number K971992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date August 01, 1997
Days to Decision 64 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
67d faster than avg
Panel avg: 131d · This submission: 64d
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 K971992.
C3 EXTERNAL MALE BLADDER CONTROL DEVICE
K974040 · Timm Research Co. · Jul 1998
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
K970308 · Mentor Urology, Inc. · Apr 1997
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