510(k) · Cleared
ClearedPubouurethral Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Jan 28, 1998 after a 90-day review. The FDA summary names its predicate without a number. 83 later devices descend from it.
- Decided
- Jan 28, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 0
83 later devices descend from it, 12 citing it directly.
- This deviceK974098 Pubouurethral SlingETHICON, Inc. · 1998
- Descendant · cites it directly · 38 of its ownK020110 Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002
- Descendant · 2 generations on · 27 of its ownK041632 Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 19 of its ownK020652 Herniamesh T-SlingHerniamesh · 2002
- Descendant · 3 generations on · 16 of its ownK053361 Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2006 · Recalled
- Descendant · cites it directly · 15 of its ownK031767 Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K020110Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002 · cites it directly38descendants
- K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2004 · 2 generations on27descendants
- K020652Herniamesh T-SlingHerniamesh · 2002 · cites it directly19descendants
- K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2006 · 3 generations on16descendants
- K031767Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| +1 | K020110 | Modification to Trelex Mesh Surgical Mesh | Boston Scientific | 2002 | — |
| +2 | K041632 | Minimesh Polypropylene Mesh | Mpathy Medical Devices, Ltd. | 2004 | 1 |
| +1 | K020652 | Herniamesh T-Sling | Herniamesh | 2002 | — |
| +3 | K053361 | Modification to: Minimesh Polypropylene Mesh | Mpathy Medical Devices, Ltd. | 2006 | 1 |
| +1 | K031767 | Mentor Obtape Trans-Obturator Tape | Mentor Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | — | ProteGen Sling Collagen Impregnated Material Named without a submission number |
What descends from it? (83)
See all 8312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020110 | Modification to Trelex Mesh Surgical Mesh | 2002 | 38 |
| K020652 | Herniamesh T-Sling | 2002 | 19 |
| K031767 | Mentor Obtape Trans-Obturator Tape | 2003 | 15 |
| K020007 | Safyre Sling System | 2002 | 7 |
| K100485 | Gynecare TVT Exact Continence System | 2010 | 4 |
| K041176 | Uretex to Trans-Obturator Urethral Support System | 2004 | 4 |
| K023898 | Gyne Ideas Minitape RP Device | 2003 | 4 |
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE… | 2018 | 1 |
| K052175 | I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000 | 2005 | 1 |
| K092203 | Omnisure Urethral Sling, Model OTK52 | 2009 | 0 |
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?
- Of its descendants, K020110 (Boston Scientific, 2002) has gone furthest, with 38 descendants of its own.
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 TVT device is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypemmobility and/or intrinsic sphincter deficiency. The TVT Introducer and Rigid Catheter Guide accessories are intended to facilitate placement of the TVT device. The accessories, available separately, are provided non-sterile and are reusable.
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/K974098 · printed Nov 3, 2026
Cite this page
510(k) Report. “K974098: Pubouurethral Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K974098
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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