510(k) · Cleared
ClearedGynecare TVT Exact Continence 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 Aug 23, 2013 as substantially equivalent to K100485 (ETHICON, Inc., 2010) after a 51-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Aug 23, 2013
- Review
- 51 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974098 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK974098 Pubouurethral SlingETHICON, Inc. · 1998
- 1 generation backK100485 Gynecare TVT Exact Continence SystemETHICON, Inc. · 2010
- This deviceK132054 Gynecare TVT Exact Continence SystemETHICON, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK173019 GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid…ETHICON, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK210087 Athena Surgical RMUS SystemAthena Surgical, LLC · 2021
- Descendant · cites it directly · 0 of its ownK201686 GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System…ETHICON, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE…ETHICON, Inc. · 2018 · cites it directly1descendant
- K210087Athena Surgical RMUS SystemAthena Surgical, LLC · 2021 · cites it directly0descendants
- K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™…ETHICON, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| −1 | K100485 | Gynecare TVT Exact Continence System | ETHICON, Inc. | 2010 | — |
| 0 (this device) | K132054 | Gynecare TVT Exact Continence System | ETHICON, Inc. | 2013 | — |
| +1 | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide… | ETHICON, Inc. | 2018 | — |
| +1 | K210087 | Athena Surgical RMUS System | Athena Surgical, LLC | 2021 | — |
| +1 | K201686 | GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE… | ETHICON, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K100485 | Gynecare TVT Exact Continence System Our reading of the summary gave K110485, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GYNECARE TVT EXACT Continence System”. | 2010 |
What descends from it? (3)
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?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 12.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173019 (ETHICON, Inc., 2018) has gone furthest, with 1 descendant 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. 2013, 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 EXACr-M Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, resulting from urethra; hypermobility and/or intrinsic sphincter deficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132054: Gynecare TVT Exact Continence System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132054
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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