510(k) · Cleared
ClearedGYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
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 Aug 10, 2018 as substantially equivalent to K100936 (ETHICON, Inc., 2010) and 1 other predicate after a 101-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Aug 10, 2018
- Review
- 101 days
- Class
- Class II
- Product code
- PWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K033568 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK033568 Gynecare TVT Obturator SystemETHICON, Inc. · 2003
- 1 generation backK100936 Gynecare TVT Abbrevo Continence SystemETHICON, Inc. · 2010
- This deviceK181151 GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator…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 |
|---|---|---|---|---|---|
| −2 | K033568 | Gynecare TVT Obturator System | ETHICON, Inc. | 2003 | — |
| −1 | K100936 | Gynecare TVT Abbrevo Continence System | ETHICON, Inc. | 2010 | — |
| 0 (this device) | K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | 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 |
|---|---|---|---|
| * | K100936 | Gynecare TVT Abbrevo Continence SystemSummary page 5…510(k) Device Company Code Number GYNECARE Ethicon, Inc. OTN K100936 TVT ABBREVO™ Continence System (Helical Passers and Winged Guide) GYNECARE Ethicon, Inc. OTN… | 2010 |
| * | K033568 | Gynecare TVT Obturator SystemSummary page 5…OTN K100936 TVT ABBREVO™ Continence System (Helical Passers and Winged Guide) GYNECARE Ethicon, Inc. OTN K033568 TVT Obturator Continence System (Helical Passers and Winged Guide) The predicate devices have not been subject to a… | 2003 |
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 15 years and passes through 1 company; a new generation was cleared every 8.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201686 (ETHICON, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K100936.
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 ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device.
The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181151: GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator 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/K181151
Report an extraction error
Are you the manufacturer?
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