510(k) · Cleared
ClearedBoston Scientific Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on Aug 27, 2008 as substantially equivalent to K073703 (American Medical Systems, Inc., 2008) after a 114-day review. Its family tree reaches back 8 generations to 2001. 5 later devices descend from it.
- Decided
- Aug 27, 2008
- Review
- 114 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K011251 (2001). 5 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 7 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 6 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 5 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 4 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
- 2 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 1 generation backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- This deviceK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
- Descendant · cites it directly · 3 of its ownK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK101440 GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK172565 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device…Boston Scientific Corporation · 2017
- Descendant · cites it directly · 0 of its ownK103022 KIMNeomedic International S.L. · 2011
- Descendant · 2 generations on · 0 of its ownK111219 GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · cites it directly3descendants
- K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010 · 2 generations on1descendant
- K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation · 2017 · cites it directly0descendants
- K103022KIMNeomedic International S.L. · 2011 · cites it directly0descendants
- K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −7 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −6 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −5 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −4 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −3 | K070065 | Ams Single Incision Sling System (Sis-0) | American Medical Systems, Inc. | 2007 | — |
| −2 | K071902 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2007 | — |
| −1 | K073703 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2008 | — |
| 0 (this device) | K081275 | Boston Scientific Surgical Mesh | Boston Scientific Corp | 2008 | — |
| +1 | K083471 | GMD Universal Sling, Model Product Code 1010 and 1020 | Generic Medical Device, Inc. | 2009 | 2 |
| +2 | K101440 | GMD Universal Urinary Incontinence Sling, Model 1012 | Generic Medical Devices, Inc. | 2010 | — |
| +1 | K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery… | Boston Scientific Corporation | 2017 | — |
| +1 | K103022 | KIM | Neomedic International S.L. | 2011 | — |
| +2 | K111219 | GMD Universal Urinary Incontinence Sling | Generic Medical Device, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2017 | 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 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? (6)
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 |
|---|---|---|---|
| * | K073703 | Ams Miniarc Sling SystemSummary page 1…n Name:(PA#)- Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II Premarket Notification: Boston Scientific Corporation: K020110, K040787 : American Medical System,Inc.; K073703 E. Device Description The proposed device is a sterile, single use device, consisting of a synthetic mesh sling assembly and pac… | 2008 |
| * | — | Advantage® Transvaginal Mid Urethral Sling System Named without a submission number | |
| * | — | Advantage Fit™ System Named without a submission number | |
| * | — | Lynx® Suprapubic Mid Urethral Sling System Named without a submission number | |
| * | — | Obtryx® Transobturator Mid Urethral Sling System Named without a submission number | |
| * | — | Prefyx PPS® System Named without a submission number |
What descends from it? (5)
3 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 7 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K083471 (Generic Medical Device, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K073703.
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. 2008, this device’s year, is highlighted.
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 mesh implant is intended for use as a suburethral sling for the treatment of stress 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/K081275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081275: Boston Scientific Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081275
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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