Cleared Traditional

NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY (K905181) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905181 · Meadox Surgimed, Inc. · Gastroenterology & Urology device
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Mar 1991
Decision
107d
Days
Class 2
Risk

K905181 is an FDA 510(k) clearance for the NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on March 6, 1991 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K905181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1990
Decision Date March 06, 1991
Days to Decision 107 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
23d faster than avg
Panel avg: 130d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 20
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K905181.
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
K933011 · Boston Scientific Corp · Feb 1994
UROLOGICAL BALLOON DILATATION CATHETER
K920946 · Boston Scientific Corp · Jul 1992
CATHETER, URETERAL DILATOR
K914617 · Boston Scientific Corp · Dec 1991
URETERAL BALLOON DILATATION CATHETER
K903813 · Boston Scientific Corp · Nov 1990