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 Mar 16, 2010 as substantially equivalent to K974098 (ETHICON, Inc., 1998) after a 25-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Mar 16, 2010
- Review
- 25 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974098 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974098 Pubouurethral SlingETHICON, Inc. · 1998
- This deviceK100485 Gynecare TVT Exact Continence SystemETHICON, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK132054 Gynecare TVT Exact Continence SystemETHICON, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK173019 GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid…ETHICON, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK210087 Athena Surgical RMUS SystemAthena Surgical, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK201686 GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System…ETHICON, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K132054Gynecare TVT Exact Continence SystemETHICON, Inc. · 2013 · cites it directly3descendants
- K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE…ETHICON, Inc. · 2018 · 2 generations on1descendant
- K210087Athena Surgical RMUS SystemAthena Surgical, LLC · 2021 · 2 generations on0descendants
- K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™…ETHICON, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| 0 (this device) | K100485 | Gynecare TVT Exact Continence System | ETHICON, Inc. | 2010 | — |
| +1 | K132054 | Gynecare TVT Exact Continence System | ETHICON, Inc. | 2013 | — |
| +2 | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide… | ETHICON, Inc. | 2018 | — |
| +2 | K210087 | Athena Surgical RMUS System | Athena Surgical, LLC | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K974098 | Pubouurethral SlingSummary page 1…vice: Class Il in 21 CFR § 878.3300, Surgical Mesh(OTN) Trade Namé: GYNECARE TVT EXACT™ Continence System Predicate Devices: GYNECARE TVT™ Tension-free Vaginal Tape (K974098), ETHICON, Inc. Statement of Intended Use: The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral s… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132054 | Gynecare TVT Exact Continence System | 2013 | 3 |
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?
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. 2010, 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 EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, 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/K100485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100485: 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/K100485
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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