Cleared Traditional

K914905 - ENTRAC(TM) URETHRAL MEASURING CATHETER

K914905 is an FDA 510(k) clearance for ENTRAC(TM) URETHRAL MEASURING CATHETER, manufactured by American Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K914905 · American Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
140d
Days
Class 2
Risk

K914905 is an FDA 510(k) clearance for the ENTRAC(TM) URETHRAL MEASURING CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 20, 1992 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K914905

510(k) Number K914905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1991
Decision Date March 20, 1992
Days to Decision 140 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
9d slower than avg
Panel avg: 131d · This submission: 140d
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 70
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K914905.
ALL SILICONE INTERMITTENT CATHETER
K943851 · Rochester Medical Corp. · Jan 1995
URI-CATH CATHETER
K941672 · Gesco Intl., Inc. · May 1994
WALTHER CATHETERS, MALE, FEMALE
K926369 · Thomasville Medical Assoc. · May 1993
AUTOCATH(TM) SET
K910876 · Cook Urological, Inc. · May 1991
ALBERT MORTON UROLOGICAL CATHETER
K901441 · Transinternational Marketing Group · Jun 1990
ASI HEMOSTASIS CATHETER
K901336 · Advanced Surgical Intervention, Inc. · Jun 1990
K914905 · ENTRAC(TM) URETHRAL MEASURING CATHETER
Download PDF FDA Summary American Medical Syst…