510(k) · Cleared
ClearedGynecare Tension-Free Vaginal Tape System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynecare Center · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Oct 26, 2001 after a 74-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Oct 26, 2001
- Review
- 74 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 4 citing it directly.
- This deviceK012628 Gynecare Tension-Free Vaginal Tape SystemGynecare Center · 2001
- Descendant · cites it directly · 13 of its ownK050516 T-SlingHerniamesh S.R.L. · 2006
- Descendant · 2 generations on · 10 of its ownK072456 Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK101169 Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010
- Descendant · 4 generations on · 3 of its ownK112609 Desara MeshCaldera Medical, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K050516T-SlingHerniamesh S.R.L. · 2006 · cites it directly13descendants
- K072456Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc. · 2008 · 2 generations on10descendants
- K101169Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010 · 3 generations on5descendants
- K112609Desara MeshCaldera Medical, Inc. · 2011 · 4 generations on3descendants
- K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012628 | Gynecare Tension-Free Vaginal Tape System | Gynecare Center | 2001 | — |
| +1 | K050516 | T-Sling | Herniamesh S.R.L. | 2006 | — |
| +2 | K072456 | Desara Mesh Sling, Model Cal-DS01 | Caldera Medical, Inc. | 2008 | — |
| +3 | K101169 | Desara Mesh Model: Cal-DS01 | Caldera Medical, Inc. | 2010 | — |
| +4 | K112609 | Desara Mesh | Caldera Medical, Inc. | 2011 | — |
| +3 | K083471 | GMD Universal Sling, Model Product Code 1010 and 1020 | Generic Medical Device, Inc. | 2009 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (4)
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 Tension Free Vaginal Tape (TVT) System with Accessories Named without a submission number | |
| * | — | TVT Reusable Introducer Named without a submission number | |
| * | — | TVT Reusable Rigid Catheter Guide Named without a submission number | |
| * | — | Cook OB/GYN Stamey Needle Named without a submission number |
What descends from it? (18)
See all 184 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, K050516 (Herniamesh S.R.L., 2006) has gone furthest, with 13 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 intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI) for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer, Rigid Catheter Guide and TVT Abdominal Guides and Couplers are accessories intended to facilitate placement of the TVT device.
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/K012628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012628: Gynecare Tension-Free Vaginal Tape System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012628
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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