Cleared Traditional

K050008 - MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER

K050008 is an FDA 510(k) clearance for MENTOR SELF-CATH HYDROGEL INTERMITTENT ..., manufactured by Mentor Corp.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K050008 · Mentor Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
151d
Days
Class 2
Risk

K050008 is an FDA 510(k) clearance for the MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on June 3, 2005 after a review of 151 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Mentor Corp. devices

FDA 510(k) Submission Details - K050008

510(k) Number K050008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2005
Decision Date June 03, 2005
Days to Decision 151 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 131d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZD Catheter, Straight

All 73
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K050008.
EXPRESSWAY INTERMITTENT CATHETER
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K062444 · Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · Feb 2007
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
K052440 · Mentor Corporation · Oct 2005
BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER
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MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
K993226 · Memcath Technologies, LLC · Dec 1999
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
K973546 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1997