510(k) · Cleared
ClearedNeedleless Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialities Remeex International, S.L. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on Dec 19, 2006 as substantially equivalent to K052401 (ETHICON, Inc., 2005) after a 64-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Dec 19, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052401 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK052401 Gynecare TVT Secur SystemETHICON, Inc. · 2005
- This deviceK063136 Needleless SlingSpecialities Remeex International, S.L. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052401 | Gynecare TVT Secur System | ETHICON, Inc. | 2005 | — |
| 0 (this device) | K063136 | Needleless Sling | Specialities Remeex International, S.L. | 2006 | — |
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 PAH? 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 PAH device
- #1 K242473 Altis Single Incision Sling System (519650)…score 10.9 · 10 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K052401 | Gynecare TVT Secur SystemSummary page 1…ethral sling for the treatment of female stress urinary incontinence: Gynecare Tension-Fre 10/26/2001 Female Urinary Vaginal Tape System Incontinence Gynecare TVT Secur K052401 11/28/2005 Female Urinary System Incontinence Technologically, both the proposed and predicate devices are the same (i.e. both a… | 2005 |
| * | — | Gynecare Tension-Free Vaginal Tape System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K052401.
How does its category compare?
All PAH devicesPAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PAH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PAH
128in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAH
242in 2025
MAUDE reports naming product code PAH, 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 | 61 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 4 | 128 | 0 | 129 |
| 2013 | 0 | — | 0 | 2,386 |
| 2014 | 0 | — | 0 | 338 |
| 2015 | 0 | — | 1 | 275 |
| 2016 | 0 | — | 0 | 697 |
| 2017 | 0 | — | 0 | 127 |
| 2018 | 0 | — | 0 | 174 |
| 2019 | 0 | — | 0 | 298 |
| 2020 | 1 | — | 0 | 171 |
| 2021 | 0 | — | 0 | 318 |
| 2022 | 0 | — | 0 | 159 |
| 2023 | 1 | — | 0 | 154 |
| 2024 | 1 | — | 0 | 287 |
| 2025 | 0 | — | 0 | 242 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NEEDLELESS SLING is indicated for the treatment of stress urinary incontinence (SUI), for female 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/K063136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063136: Needleless Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063136
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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