510(k) · Cleared
ClearedUretex Sup Pubourethral Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofradim Production · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Oct 4, 2001 as substantially equivalent to K974098 (ETHICON, Inc., 1998) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Oct 4, 2001
- Review
- 30 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. No later device cites it as a predicate yet.
- Root · 1 generation backK974098 Pubouurethral SlingETHICON, Inc. · 1998
- This deviceK012949 Uretex Sup Pubourethral SlingSofradim Production · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| 0 (this device) | K012949 | Uretex Sup Pubourethral Sling | Sofradim Production | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
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 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974098 | Pubouurethral SlingSummary page 1…(0)4 74 08 90 02 DEVICE NAME Proprietary Name: URETEX SUP® Device Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh PREDICATE DEVICES Ethicon TVT K974098 Sofradim Parietene® Meshes K991400 Mentor Sling K980483 DEVICE DESCRIPTION The URETEX® SUP Pubourethral Sling is used in gynecol… | 1998 |
| * | K991400 | Parietene Polypropylene MeshSummary page 1…prietary Name: URETEX SUP® Device Common/Usual Name: Surgical Mesh Classification Name: 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… | 1999 |
| * | K980483 | Mentor Suspend SlingSummary page 1…SUP® Device Common/Usual Name: Surgical Mesh Classification Name: 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 incontinen… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 11 other devices also cite its predicate K974098.
How does its category compare?
All OTN devicesOTN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · OTN
89in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTN
458in 2025
MAUDE reports naming product code OTN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 3 | 100 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 5 | 25 | 0 | 1 |
| 2011 | 4 | 56 | 0 | 25 |
| 2012 | 1 | — | 0 | 874 |
| 2013 | 5 | 86 | 0 | 19,084 |
| 2014 | 1 | — | 1 | 2,063 |
| 2015 | 0 | — | 0 | 3,904 |
| 2016 | 0 | — | 0 | 1,902 |
| 2017 | 1 | — | 0 | 676 |
| 2018 | 0 | — | 0 | 737 |
| 2019 | 1 | — | 0 | 2,457 |
| 2020 | 1 | — | 0 | 1,003 |
| 2021 | 3 | 89 | 0 | 2,606 |
| 2022 | 2 | — | 0 | 809 |
| 2023 | 1 | — | 0 | 1,076 |
| 2024 | 0 | — | 0 | 822 |
| 2025 | 0 | — | 0 | 458 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The URETEX® SUP device is intended to be used as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility 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.
https://510kreport.com/device/K012949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012949: Uretex Sup Pubourethral Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012949
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026