Cleared Traditional

K810371 - VANCE URETHAL DILATOR SET

K810371 is an FDA 510(k) clearance for VANCE URETHAL DILATOR SET, manufactured by Vance Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOE cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K810371 · Vance Products, Inc. · Gastroenterology & Urology device
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Mar 1981
Decision
36d
Days
Class 2
Risk

K810371 is an FDA 510(k) clearance for the VANCE URETHAL DILATOR SET. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Vance Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 20, 1981 after a review of 36 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 Vance Products, Inc. devices

FDA 510(k) Submission Details - K810371

510(k) Number K810371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1981
Decision Date March 20, 1981
Days to Decision 36 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
95d faster than avg
Panel avg: 131d · This submission: 36d
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 21
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K810371.
KOLLMANN URETHRAL DILATOR
K841386 · Imm Enterprises , Ltd. · May 1984
URETERAL DILATOR
K840746 · American Edwards Laboratories · Apr 1984
VNACE FASCIAL DILATOR SET
K811833 · Vance Products, Inc. · Jul 1981
URETHRAL SOUND
K800610 · G.D. Searle and Co. · Apr 1980
BOUGIE A BOULE
K800611 · G.D. Searle and Co. · Apr 1980
VANCE MALLEABLE TIP FILIFORM
K792219 · Vance Products, Inc. · Dec 1979