510(k) Report

510(k) · Cleared

Cleared

Uretex to Trans-Obturator Urethral Support System

K041176510(k) SpecialCleared May 17, 200412-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sofradim Production · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on May 17, 2004 as substantially equivalent to K974098 (ETHICON, Inc., 1998) and 2 other predicates after a 12-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.

Decided
May 17, 2004
Review
12 days
Class
Class II
Product code
OTN
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K974098 (1998). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 1 other ancestor2007: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant clearedK974098 · Pubouurethral Sling · ETHICON, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants K974098 · Pubouurethral Sling · ETHICON, Inc. · 19980
  1. Root · 1 generation backK974098 Pubouurethral SlingETHICON, Inc. · 1998
  2. This deviceK041176 Uretex to Trans-Obturator Urethral Support SystemSofradim Production · 2004
  3. Descendant · cites it directly · 1 of its ownK070073 Align Urethral Support SystemC.R. Bard, Inc. · 2007
  4. Descendant · cites it directly · 1 of its ownK051533 I-STOPCl Medical · 2005
  5. Descendant · 2 generations on · 0 of its ownK093747 Align and Align to Urethral Support SystemsC.R. Bard, Inc. · 2010
  6. Descendant · 2 generations on · 0 of its ownK063079 I-Stop Trans Obturator Male SlingCl Medical · 2006

Most influential descendants

Showing 4 of 4 · See all
  • K070073Align Urethral Support SystemC.R. Bard, Inc. · 2007 · cites it directly1descendant
  • K051533I-STOPCl Medical · 2005 · cites it directly1descendant
  • K093747Align and Align to Urethral Support SystemsC.R. Bard, Inc. · 2010 · 2 generations on0descendants
  • K063079I-Stop Trans Obturator Male SlingCl Medical · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K974098Pubouurethral SlingETHICON, Inc.1998—
0 (this device)K041176Uretex to Trans-Obturator Urethral Support SystemSofradim Production2004—
+1K070073Align Urethral Support SystemC.R. Bard, Inc.2007—
+1K051533I-STOPCl Medical2005—
+2K093747Align and Align to Urethral Support SystemsC.R. Bard, Inc.2010—
+2K063079I-Stop Trans Obturator Male SlingCl Medical2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
201010
FIG. 1 — Lineage of K041176, 1998–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OTN device

  1. #1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K974098Pubouurethral Sling
Summary page 1
…3 (0)4 74 08 90 02 DEVICE NAME Proprietary Name: URETEX SUP® Device Common/Usual Name: Surgical Mesh Classification Namc: Surgical Mesh PREDICATE DEVICES Ethicon TVT K974098 Sofradim Parietene® Meshes K991400 Mentor Sling K980483 DEVICE DESCRIPTION The URETEX® SUP Pubourethral Sling is used in gyne…
ETHICON, Inc.1998—
*K991400Parietene Polypropylene Mesh
Summary page 1
…prietary Name: URETEX SUP® Device Common/Usual Name: Surgical Mesh Classification Namc: Surgical Mesh PREDICATE DEVICES Ethicon TVT K974098 Sofradim Parietene® Meshes K991400 Mentor Sling K980483 DEVICE DESCRIPTION The URETEX® SUP Pubourethral Sling is used in gynecological procedures for the treatme…
Sofradim Production1999—
*K980483Mentor Suspend Sling
Summary page 1
…SUP® Device Common/Usual Name: Surgical Mesh Classification Namc: Surgical Mesh PREDICATE DEVICES Ethicon TVT K974098 Sofradim Parietene® Meshes K991400 Mentor Sling K980483 DEVICE DESCRIPTION The URETEX® SUP Pubourethral Sling is used in gynecological procedures for the treatment of stress incontine…
Mentor Corp.1998—

Also cleared against K974098: 11 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070073Align Urethral Support SystemC.R. Bard, Inc.20071
K051533I-STOPCl Medical20051

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K070073 (C.R. Bard, Inc., 2007) has gone furthest, with 1 descendant of its own.
  • 11 other devices also cite its predicate K974098.

How does its category compare?

All OTN devices

OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OTN

1in 2023

2007: 22008: 32009: 22010: 52011: 42012: 12013: 52014: 12017: 12019: 12020: 12021: 32022: 22023: 12026 (partial year): 1
2007high 5 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTN

89in 2021

2008: 100 days median2010: 25 days median2011: 56 days median2013: 86 days median2021: 89 days median
2007high 100 (2008) · low 25 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OTN

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OTN

458in 2025

2010: 12011: 252012: 8742013: 19,0842014: 2,0632015: 3,9042016: 1,9022017: 6762018: 7372019: 2,4572020: 1,0032021: 2,6062022: 8092023: 1,0762024: 8222025: 458
2007high 19,084 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
2008310000
20092—00
201052501
2011456025
20121—0874
2013586019,084
20141—12,063
20150—03,904
20160—01,902
20171—0676
20180—0737
20191—02,457
20201—01,003
202138902,606
20222—0809
20231—01,076
20240—0822
20250—0458
20261—0—

What is it indicated for?

The URETEX® TO Trans-Obturator Urethral Support System is indicated for the treatment of female stress urinary incontinence from urethral hyper mobility and/or intrinsic sphincter deficiency.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K974098

11 other devices cite the same predicate.

  • K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence…ETHICON, Inc. · 2018
  • K100485Gynecare TVT Exact Continence SystemETHICON, Inc. · 2010
  • K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
  • K052175I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000Uroplasty, Inc. · 2005
  • K031767Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003
  • K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd. · 2003

More from Sofradim Production

43 FDA decisions under this applicant name. See the company

  • K262443Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)Sofradim Production · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production · 2025
  • K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
  • K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production · 2024

Recent decisions in OTN

The OTN category page

  • K262284Kim BlueDesarrollo e Investigación Médica Aragonesa S.L. · 2026
  • K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2023
  • K222293ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
  • K222468ArcTO Transobturator Sling SystemUrocure, LLC · 2022
  • K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc. · 2021

https://510kreport.com/device/K041176 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041176: Uretex to Trans-Obturator Urethral Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041176

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026