Cleared Traditional

K012949 - URETEX SUP PUBOURETHRAL SLING

K012949 is the FDA 510(k) clearance for URETEX SUP PUBOURETHRAL SLING by Sofradim Production. It is a Class 2 Gastroenterology & Urology device (product code OTN) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K012949 · Sofradim Production · Gastroenterology & Urology device
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Oct 2001
Decision
30d
Days
Class 2
Risk

K012949 is an FDA 510(k) clearance for the URETEX SUP PUBOURETHRAL SLING. 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 October 4, 2001 after a review of 30 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. 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 Sofradim Production devices

Submission Details

510(k) Number K012949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2001
Decision Date October 04, 2001
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K012949.
MODIFICATION TO TRELEX MESH SURGICAL MESH
K020110 · Boston Scientific · Apr 2002
MODIFICATION TO SPARC SLING SYSTEM
K020663 · American Medical Systems, Inc. · Mar 2002
SPARC SLING SYSTEM
K013355 · American Medical Systems, Inc. · Oct 2001
SPARC SLING SYSTEM
K011251 · American Medical Systems, Inc. · Aug 2001
PUBOUURETHRAL SLING
K974098 · Ethicon, Inc. · Jan 1998