Cleared Traditional

K870695 - VAN-TEC URETHRAL DILATATION SYSTEM

K870695 is the FDA 510(k) clearance for VAN-TEC URETHRAL DILATATION SYSTEM by Van-Tec, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOE) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K870695 · Van-Tec, Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
19d
Days
Class 2
Risk

K870695 is an FDA 510(k) clearance for the VAN-TEC URETHRAL DILATATION SYSTEM. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 10, 1987 after a review of 19 days - a notably fast clearance 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: 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 Van-Tec, Inc. devices

Submission Details

510(k) Number K870695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1987
Decision Date March 10, 1987
Days to Decision 19 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 130d · This submission: 19d
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 14
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K870695.
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · American Medical Systems, Inc. · May 1990
URETHRAL BALLOON DILATION CATHETER SET
K892855 · Cook Urological, Inc. · Nov 1989
PROSTATIC URETHRO. BALLOON DILATATION CATHETER
K873295 · Medi-Tech, Inc. · Jul 1989
VAN-TEC MEATAL DILATOR
K851158 · Van-Tec, Inc. · Apr 1985
KOLLMANN URETHRAL DILATOR
K841386 · Imm Enterprises , Ltd. · May 1984
URETERAL DILATOR
K840746 · American Edwards Laboratories · Apr 1984