Cleared Traditional

K873295 - PROSTATIC URETHRO. BALLOON DILATATION C...

K873295 is the FDA 510(k) clearance for PROSTATIC URETHRO. BALLOON DILATATION C... by Medi-Tech, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOE) cleared through the Traditional 510(k) pathway after a 714-day FDA review.

K873295 · Medi-Tech, Inc. · Gastroenterology & Urology device
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Jul 1989
Decision
714d
Days
Class 2
Risk

K873295 is an FDA 510(k) clearance for the PROSTATIC URETHRO. BALLOON DILATATION CATHETER. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Watertown, US). The FDA issued a Cleared decision on July 31, 1989 after a review of 714 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Medi-Tech, Inc. devices

Submission Details

510(k) Number K873295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date July 31, 1989
Days to Decision 714 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
584d slower than avg
Panel avg: 130d · This submission: 714d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K873295.
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
URETERAL DILATOR
K840746 · American Edwards Laboratories · Apr 1984