510(k) · Cleared
ClearedGYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
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 Sep 17, 2020 as substantially equivalent to K012628 (Gynecare Center, 2001) and 6 other predicates after an 87-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Sep 17, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K974098 (1998). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK974098 Pubouurethral SlingETHICON, Inc. · 1998
- 3 generations backK100485 Gynecare TVT Exact Continence SystemETHICON, Inc. · 2010
- 2 generations backK132054 Gynecare TVT Exact Continence SystemETHICON, Inc. · 2013
- 1 generation backK173019 GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid…ETHICON, Inc. · 2018
- This deviceK201686 GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System…ETHICON, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| −3 | K100485 | Gynecare TVT Exact Continence System | ETHICON, Inc. | 2010 | — |
| −2 | K132054 | Gynecare TVT Exact Continence System | ETHICON, Inc. | 2013 | — |
| −1 | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide… | ETHICON, Inc. | 2018 | — |
| 0 (this device) | K201686 | GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE… | ETHICON, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 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 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? (7)
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 |
|---|---|---|---|
| * | K012628 | Gynecare Tension-Free Vaginal Tape SystemSummary page 5…Device Product Code 510(k) Product Code 510(k) GYNECARE TVT™ Tension-free OTN K012628 PWJ K173019 Vaginal Tape (TVT System)… | 2001 |
| * | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE…Summary page 5…Product Code 510(k) Product Code 510(k) GYNECARE TVT™ Tension-free OTN K012628 PWJ K173019 Vaginal Tape (TVT System) PWJ K173019… | 2018 |
| * | K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE…Summary page 5…GYNECARE TVT™ Reusable (Reusable Instruments only) Introducer PWJ K173162 K201686… | 2018 |
| * | K132054 | Gynecare TVT Exact Continence SystemSummary page 6…OTN K012628 PWJ K173162 Guides Tension-Free Support for Incontinence System GYNECARE TVT EXACT™ OTN K132054 PWJ K173019 Continence System GYNECARE TVT™ Obturator OTN K033568… | 2013 |
| * | K033568 | Gynecare TVT Obturator SystemSummary page 6…TVT EXACT™ OTN K132054 PWJ K173019 Continence System GYNECARE TVT™ Obturator OTN K033568 PWJ K181151 System GYNECARE TVT ABBREVO™ Continence System OTN K10093… | 2003 |
| * | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemSummary page 6…OTN K132054 PWJ K173019 Continence System GYNECARE TVT™ Obturator OTN K033568 PWJ K181151 System GYNECARE TVT ABBREVO™ Continence System OTN K100936 PWJ K18115… | 2018 |
| * | K100936 | Gynecare TVT Abbrevo Continence SystemSummary page 6…tor OTN K033568 PWJ K181151 System GYNECARE TVT ABBREVO™ Continence System OTN K100936 PWJ K181151 Device Description: GYNECARE TVT™ Tension-free Vaginal Tape System GYNECARE TVT™ Device is a s… | 2010 |
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?
- The line of descent spans 22 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- None of the 9 ancestors has a recall.
- 3 other devices also cite its predicate K012628.
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. 2020, this device’s year, is highlighted.
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 Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device. The GYNECARE TVT Device is intended to be used as a pubo-urethral sling…
Read the full statement (387 words)
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.
The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device.
The GYNECARE TVT Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT Device when placed in a top-down retropubic fashion (also known as an abdominal approach).
The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT EXACT Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.
The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT EXACT Continence System.
The GYNECARE TVT Obturator Device is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.
The GYNECARE TVT ABBREVO Continence System is intended for use in women as a sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO 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/K201686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201686: GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201686
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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