510(k) · Cleared
ClearedGynecare TVT Obturator System
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 Dec 8, 2003 after a 26-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Dec 8, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 6 citing it directly.
- This deviceK033568 Gynecare TVT Obturator SystemETHICON, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK100936 Gynecare TVT Abbrevo Continence SystemETHICON, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK181151 GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator…ETHICON, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK101440 GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK051533 I-STOPCl Medical · 2005
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K100936Gynecare TVT Abbrevo Continence SystemETHICON, Inc. · 2010 · cites it directly3descendants
- K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · cites it directly3descendants
- K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemETHICON, Inc. · 2018 · cites it directly1descendant
- K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010 · 2 generations on1descendant
- K051533I-STOPCl Medical · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033568 | Gynecare TVT Obturator System | ETHICON, Inc. | 2003 | — |
| +1 | K100936 | Gynecare TVT Abbrevo Continence System | ETHICON, Inc. | 2010 | — |
| +1 | K083471 | GMD Universal Sling, Model Product Code 1010 and 1020 | Generic Medical Device, Inc. | 2009 | 2 |
| +1 | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | ETHICON, Inc. | 2018 | — |
| +2 | K101440 | GMD Universal Urinary Incontinence Sling, Model 1012 | Generic Medical Devices, Inc. | 2010 | — |
| +1 | K051533 | I-STOP | Cl Medical | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | — | GYNECARE TVT device Named without a submission number |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100936 | Gynecare TVT Abbrevo Continence System | 2010 | 3 |
| K083471 | GMD Universal Sling, Model Product Code 1010 and 1020 | 2009 | 3 |
| K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | 2018 | 1 |
| K051533 | I-STOP | 2005 | 1 |
| K201686 | GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™… | 2020 | 0 |
| K103022 | KIM | 2011 | 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, K100936 (ETHICON, Inc., 2010) has gone furthest, with 3 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 GYNECARE TVT Obturator 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/K033568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033568: Gynecare TVT Obturator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033568
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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