Cleared Traditional

K992137 - UROLOGICAL CATHETER

K992137 is an FDA 510(k) clearance for UROLOGICAL CATHETER, manufactured by Apogee, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K992137 · Apogee, Inc. · Gastroenterology & Urology device
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Sep 1999
Decision
71d
Days
Class 2
Risk

K992137 is an FDA 510(k) clearance for the UROLOGICAL CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Apogee, Inc. (Raleigh, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Apogee, Inc. devices

FDA 510(k) Submission Details - K992137

510(k) Number K992137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1999
Decision Date September 03, 1999
Days to Decision 71 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
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GBM Catheter, Urethral

All 46
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K992137.
SPEEDICATH
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DILATION CATHETER, BALLOON
K965067 · Boston Scientific Corp · Jan 1997
WALTHER CATHETERS, MALE, FEMALE
K926369 · Thomasville Medical Assoc. · May 1993
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905 · American Medical Systems, Inc. · Mar 1992