Cleared Traditional

K971992 - UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K971992 · Uromed Corp. · Gastroenterology & Urology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.