510(k) · Cleared
Recalled · 2011GMD Universal Sling, Model Product Code 1010 and 1020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Generic Medical Device, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Mar 3, 2009 as substantially equivalent to K033568 (ETHICON, Inc., 2003) and 2 other predicates after a 99-day review. Its family tree reaches back 9 generations to 2001. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 3, 2009
- Review
- 99 days
- Class
- Class II
- Product code
- OTN
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 9 generations to K011251 (2001). 17 ancestors in all, the oldest K974098 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 5 generations between
- 3 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 2 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- 1 generation backK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
- This deviceK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK101440 GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK103022 KIMNeomedic International S.L. · 2011
- Descendant · cites it directly · 0 of its ownK111219 GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011
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 backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
- 3 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 2 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- 1 generation backK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
- This deviceK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc. · 2010 · cites it directly1descendant
- K103022KIMNeomedic International S.L. · 2011 · cites it directly0descendants
- K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011 · cites it directly0descendants
View 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 | K070065 | Ams Single Incision Sling System (Sis-0) | American Medical Systems, Inc. | 2007 | — |
| −3 | K071902 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2007 | — |
| −2 | K073703 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2008 | — |
| −1 | K081275 | Boston Scientific Surgical Mesh | Boston Scientific Corp | 2008 | — |
| 0 (this device) | K083471 | GMD Universal Sling, Model Product Code 1010 and 1020 | Generic Medical Device, Inc. | 2009 | — |
| +1 | K101440 | GMD Universal Urinary Incontinence Sling, Model 1012 | Generic Medical Devices, Inc. | 2010 | — |
| +1 | K103022 | KIM | Neomedic International S.L. | 2011 | — |
| +1 | K111219 | GMD Universal Urinary Incontinence Sling | Generic Medical Device, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K033568 | Gynecare TVT Obturator SystemSummary page 1…: GMD Universal Sling ™ k " Common Name: Mesh, Surgical, Polymeric Régulatory Class: Class II Product Codes: OTN Predicate Device(s): Gynecare TVT™ Obturator System (K033568), Boston Scientific Lynx™ System (K081275), Caldera Desara ™ (K(072456) DevicesDescription: The GMD Universal Sling System ™ —… | 2003 |
| * | K081275 | Boston Scientific Surgical MeshSummary page 1…Mesh, Surgical, Polymeric Régulatory Class: Class II Product Codes: OTN Predicate Device(s): Gynecare TVT™ Obturator System (K033568), Boston Scientific Lynx™ System (K081275), Caldera Desara ™ (K(072456) DevicesDescription: The GMD Universal Sling System ™ — is a sterile, singlc use device for the tr… | 2008 |
| * | K072456 | Desara Mesh Sling, Model Cal-DS01Summary page 2…nd similar technological characteristics as the predicate devices: Gynecare TVT™ Obturator System (K033568), Boston Scientific Lynx™ System (KO081275), Caldera Desara ™ (K072456). Non-Clinical Studies: Bench and animal studies were performed. The data demonstrate that the GMD Universal Sling ™ is substan… | 2008 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2011 | Not classified | Z-1390-2011 | Component design/selection | Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs. |
| Jun 18, 2009 | Not classified | Z-0268-2010 | Employee error | Product that is approved only for use outside the U.S. was shipped to two customers in the U.S. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K101440 (Generic Medical Devices, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K033568.
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. 2009, 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 GMD Universal Sling is indicated for use in women as a suburethral sling for the treatment of stress urinary incontinence (SUI) resulting from either 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/K083471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083471: GMD Universal Sling, Model Product Code 1010 and 1020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083471
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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