Cleared Traditional

K841386 - KOLLMANN URETHRAL DILATOR

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

K841386 · Imm Enterprises , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K841386

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 131d · This submission: 43d
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 20
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K841386.
PROSTATIC URETHRO. BALLOON DILATATION CATHETER
K873295 · Medi-Tech, Inc. · Jul 1989
VAN-TEC URETHRAL DILATATION SYSTEM
K870695 · Van-Tec, Inc. · Mar 1987
VAN-TEC MEATAL DILATOR
K851158 · Van-Tec, Inc. · Apr 1985
URETERAL DILATOR
K840746 · American Edwards Laboratories · Apr 1984
VNACE FASCIAL DILATOR SET
K811833 · Vance Products, Inc. · Jul 1981
VANCE URETHAL DILATOR SET
K810371 · Vance Products, Inc. · Mar 1981