Cleared Traditional

K896713 - ASI TCU PROSTATIC URETHROPLASTY CATHETE...

K896713 is an FDA 510(k) clearance for ASI TCU PROSTATIC URETHROPLASTY CATHETE..., manufactured by Advanced Surgical Intervention, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOE cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K896713 · Advanced Surgical Intervention, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 1990
Decision
176d
Days
Class 2
Risk

K896713 is an FDA 510(k) clearance for the ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Advanced Surgical Intervention, Inc. (San Clemente, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 176 days - an extended review cycle.

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 Advanced Surgical Intervention, Inc. devices

FDA 510(k) Submission Details - K896713

510(k) Number K896713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1989
Decision Date May 24, 1990
Days to Decision 176 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 130d · This submission: 176d
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 K896713.
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