510(k) · Cleared
ClearedGYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Cleared on Jul 6, 2018 as substantially equivalent to K974098 (ETHICON, Inc., 1998) and 1 other predicate after a 281-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Jul 6, 2018
- Review
- 281 days
- Class
- Class II
- Product code
- PWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K974098 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK974098 Pubouurethral SlingETHICON, Inc. · 1998
- 2 generations backK100485 Gynecare TVT Exact Continence SystemETHICON, Inc. · 2010
- 1 generation backK132054 Gynecare TVT Exact Continence SystemETHICON, Inc. · 2013
- This deviceK173019 GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid…ETHICON, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK201686 GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System…ETHICON, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −3 | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| −2 | K100485 | Gynecare TVT Exact Continence System | ETHICON, Inc. | 2010 | — |
| −1 | K132054 | Gynecare TVT Exact Continence System | ETHICON, Inc. | 2013 | — |
| 0 (this device) | K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide… | ETHICON, Inc. | 2018 | — |
| +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 |
|---|---|---|
| 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 PWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 4…ress urinary incontinence) Predicate Device: GYNECARE TVT™ Tension Free Vaginal Tape (TVT System), Ethicon, Inc., 510(k) K974098 GYNECARE TVT EXACT™ Continence System, Ethicon, Inc., 510(k) K132054… | 1998 |
| * | K132054 | Gynecare TVT Exact Continence SystemSummary page 4…TVT System), Ethicon, Inc., 510(k) K974098 GYNECARE TVT EXACT™ Continence System, Ethicon, Inc., 510(k) K132054 K173019… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201686 | GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™… | 2020 | 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?
- The line of descent spans 20 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K201686 (ETHICON, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K974098.
How does its category compare?
All PWJ devicesPWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PWJ
4in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PWJ
259in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PWJ
No recall names PWJ since 2007.
Adverse event reports per year · PWJ
2in 2025
MAUDE reports naming product code PWJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 4 | 259 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.
The GYNECARE TVT™ Reusable 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 and GYNECARE TVT EXACT Continence System.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173019: GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173019
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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