510(k) · Cleared
ClearedGYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
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 Jun 28, 2018 as substantially equivalent to K012628 (Gynecare Center, 2001) after a 272-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jun 28, 2018
- Review
- 272 days
- Class
- Class II
- Product code
- PWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012628 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK012628 Gynecare Tension-Free Vaginal Tape SystemGynecare Center · 2001
- This deviceK173162 GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable…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 |
|---|---|---|---|---|---|
| −1 | K012628 | Gynecare Tension-Free Vaginal Tape System | Gynecare Center | 2001 | — |
| 0 (this device) | K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer… | 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? (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 |
|---|---|---|---|
| * | K012628 | Gynecare Tension-Free Vaginal Tape SystemSummary page 5…urgical mesh, urogynecologic, stress urinary incontinence) Predicate Device: GYNECARE TVT™, Ethicon Women’s Health and Urology, 510(k) K012628. The predicate device has not been subject to a design related recall. Device Description The subject devices included the foll… | 2001 |
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?
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™ 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™ 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.
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/K173162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173162: GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173162
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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