510(k) · Cleared
ClearedGynecare TVT Secur System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on Nov 28, 2005 after an 88-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Nov 28, 2005
- Review
- 88 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK052401 Gynecare TVT Secur SystemETHICON, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK091180 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK092203 Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK070846 Minisling Adjustable Polymer Sling & Surgical Mesh with…Prosurg, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK063136 Needleless SlingSpecialities Remeex International, S.L. · 2006
Most influential descendants
Showing 4 of 4 · See all- K091180Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009 · cites it directly1descendant
- K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009 · 2 generations on0descendants
- K070846Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemProsurg, Inc. · 2007 · cites it directly0descendants
- K063136Needleless SlingSpecialities Remeex International, S.L. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052401 | Gynecare TVT Secur System | ETHICON, Inc. | 2005 | — |
| +1 | K091180 | Minitape Urethral Sling | Mpathy Medical Devices, Ltd. | 2009 | — |
| +2 | K092203 | Omnisure Urethral Sling, Model OTK52 | Mpathy Medical Devices, Ltd. | 2009 | — |
| +1 | K070846 | Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System | Prosurg, Inc. | 2007 | — |
| +1 | K063136 | Needleless Sling | Specialities Remeex International, S.L. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 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 PAH? 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 PAH device
- #1 K242473 Altis Single Incision Sling System (519650)…score 10.9 · 10 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | GYNECARE TVT System Named without a submission number | |
| * | — | GYNECARE TVT Obturator System Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K091180 (Mpathy Medical Devices, Ltd., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PAH devicesPAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PAH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PAH
128in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAH
242in 2025
MAUDE reports naming product code PAH, 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 | 61 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 4 | 128 | 0 | 129 |
| 2013 | 0 | — | 0 | 2,386 |
| 2014 | 0 | — | 0 | 338 |
| 2015 | 0 | — | 1 | 275 |
| 2016 | 0 | — | 0 | 697 |
| 2017 | 0 | — | 0 | 127 |
| 2018 | 0 | — | 0 | 174 |
| 2019 | 0 | — | 0 | 298 |
| 2020 | 1 | — | 0 | 171 |
| 2021 | 0 | — | 0 | 318 |
| 2022 | 0 | — | 0 | 159 |
| 2023 | 1 | — | 0 | 154 |
| 2024 | 1 | — | 0 | 287 |
| 2025 | 0 | — | 0 | 242 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) 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/K052401 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052401: Gynecare TVT Secur System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052401
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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