Cleared Traditional

K913477 - APEX(TM) PROSTATIC BALLOON DILATION CAT...

K913477 is an FDA 510(k) clearance for APEX(TM) PROSTATIC BALLOON DILATION CAT..., manufactured by Peripheral Systems Group. The device is a Class 2 Gastroenterology & Urology device with product code KOE cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K913477 · Peripheral Systems Group · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
144d
Days
Class 2
Risk

K913477 is an FDA 510(k) clearance for the APEX(TM) PROSTATIC BALLOON DILATION CATHETER. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Peripheral Systems Group (Mountain View, US). The FDA issued a Cleared decision on December 27, 1991 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5520 - 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.

View all Peripheral Systems Group devices

FDA 510(k) Submission Details - K913477

510(k) Number K913477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date December 27, 1991
Days to Decision 144 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
14d slower than avg
Panel avg: 130d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOE Device Classification - Class 2, Special Controls

Product Code KOE Dilator, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5520
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 - KOE Dilator, Urethral

All 15
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K913477.
120 FR OPTILUME PROSTATE BALLOON DILATOR
K920551 · American Medical Systems, Inc. · Oct 1992
DOWD(TM) II
K922349 · Boston Scientific Corp · Aug 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
K920711 · American Medical Systems, Inc. · May 1992
AMS OPTILUME INFLATION SYRINGE
K900760 · American Medical Systems, Inc. · May 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · American Medical Systems, Inc. · May 1990
URETHRAL BALLOON DILATION CATHETER SET
K892855 · Cook Urological, Inc. · Nov 1989