Cleared Traditional

K841386 - KOLLMANN URETHRAL DILATOR

K841386 is the FDA 510(k) clearance for KOLLMANN URETHRAL DILATOR by Imm Enterprises , Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KOE) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K841386 · Imm Enterprises , Ltd. · Gastroenterology & Urology device
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May 1984
Decision
43d
Days
Class 2
Risk

K841386 is an FDA 510(k) clearance for the KOLLMANN URETHRAL DILATOR. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 43 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 Imm Enterprises , Ltd. devices

Submission Details

510(k) Number K841386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1984
Decision Date May 09, 1984
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
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 K841386.
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