510(k) · Cleared
ClearedArcTV Transvaginal Sling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urocure, LLC · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Feb 7, 2019 as substantially equivalent to K132655 (American Medical Systems, Inc., 2013) after an 86-day review. Its family tree reaches back 9 generations to 2001. 2 later devices descend from it.
- Decided
- Feb 7, 2019
- Review
- 86 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K011251 (2001). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 5 generations between
- 3 generations backK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
- 2 generations backK081613 Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc. · 2008
- 1 generation backK132655 Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
- This deviceK183134 ArcTV Transvaginal Sling SystemUrocure, LLC · 2019
- Descendant · cites it directly · 0 of its ownK222293 ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
- Descendant · cites it directly · 0 of its ownK222468 ArcTO Transobturator Sling SystemUrocure, LLC · 2022
Show all 9 generations
- Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 8 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 7 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 6 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 5 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 4 generations backK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
- 3 generations backK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
- 2 generations backK081613 Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc. · 2008
- 1 generation backK132655 Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
- This deviceK183134 ArcTV Transvaginal Sling SystemUrocure, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −8 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −7 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −6 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −5 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −4 | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 | American Medical Systems, Inc. | 2004 | — |
| −3 | K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems | American Medical Systems, Inc. | 2004 | — |
| −2 | K081613 | Sparc System / Monarc, Monarc C, Monarc + Systems | American Medical Systems, Inc. | 2008 | — |
| −1 | K132655 | Retroarc Retropubic Sling System | American Medical Systems, Inc. | 2013 | — |
| 0 (this device) | K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | 2019 | — |
| +1 | K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | 2022 | — |
| +1 | K222468 | ArcTO Transobturator Sling System | Urocure, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K132655 | Retroarc Retropubic Sling SystemSummary page 4…tional 510(k) and is submitted to obtain marketing clearance for a new device – the ArcTV Transvaginal Sling System. 1.5 PREDICATE DEVICE RetroArc Repubic Sling System (K132655) 1.6 DEVICE DESCRIPTION The ArcTV Transvaginal Sling System is a sterile, single-use system, consisting of a Handle, two deliver… | 2013 |
What descends from it? (2)
2 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 18 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K222293 (Urocure, LLC, 2022) has gone furthest, with 0 descendants 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. 2019, 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 ArcTV Transvaginal Sling System is a retropubic sling indicated for a transvaginal (TV) placement of a mid-urethral sling for the treatment of adult female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183134: ArcTV Transvaginal Sling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183134
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