Cleared Special

K041176 - URETEX TO TRANS-OBTURATOR URETHRAL SUPP...

K041176 is the FDA 510(k) clearance for URETEX TO TRANS-OBTURATOR URETHRAL SUPP... by Sofradim Production. It is a Class 2 Gastroenterology & Urology device (product code OTN) cleared through the Special 510(k) pathway after a 12-day FDA review.

K041176 · Sofradim Production · Gastroenterology & Urology device
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May 2004
Decision
12d
Days
Class 2
Risk

K041176 is an FDA 510(k) clearance for the URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Sofradim Production (Ayer, US). The FDA issued a Cleared decision on May 17, 2004 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sofradim Production devices

Submission Details

510(k) Number K041176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2004
Decision Date May 17, 2004
Days to Decision 12 days
Submission Type Special
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
118d faster than avg
Panel avg: 130d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility
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 - OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

All 35
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K041176.
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
K042592 · American Medical Systems, Inc. · Dec 2004
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
K042851 · Mentor Corp. · Nov 2004
SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
K041948 · American Medical Systems, Inc. · Aug 2004
MODIFICATION TO SURGICAL MESH POLYMERIC
K040787 · Boston Scientific · Apr 2004
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
K040538 · American Medical Systems, Inc. · Mar 2004
GYNECARE TVT OBTURATOR SYSTEM
K033568 · Ethicon, Inc. · Dec 2003