510(k) · Cleared
ClearedMinisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosurg, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jul 2, 2007 as substantially equivalent to K010533 (Injectx, Inc., 2001) and 3 other predicates after a 96-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jul 2, 2007
- Review
- 96 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K011251 (2001). 14 ancestors in all, the oldest K974098 (1998). No later device cites it as a predicate yet.
- Root · 6 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 5 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 4 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 3 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 2 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 1 generation backK063713 Ams Smart Sling SystemAmerican Medical Systems, Inc. · 2007
- This deviceK070846 Minisling Adjustable Polymer Sling & Surgical Mesh with…Prosurg, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −5 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −4 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −3 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −2 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −1 | K063713 | Ams Smart Sling System | American Medical Systems, Inc. | 2007 | — |
| 0 (this device) | K070846 | Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System | Prosurg, Inc. | 2007 | — |
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 |
| 2005 | 1 | 0 |
| 2006 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K010533 | Biosling - Bioabsorbable Polymer Sling & Surgical MeshSummary page 1…Device Name: MiniSling TM- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System Predicated Devices: BioSling - Bioabsorbable Sling & Surgical Mesh (Ref: K 010533) Zippere - bioabsorbable / Non-Absorbable Polymer Sling & Mesh (Ref: K030631) AMS-Smart… | 2001 |
| * | K030631 | Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical MeshSummary page 1…redicated Devices: BioSling - Bioabsorbable Sling & Surgical Mesh (Ref: K 010533) Zippere - bioabsorbable / Non-Absorbable Polymer Sling & Mesh (Ref: K030631) AMS-Smart Sling System & pelvic Floor Repair System (Ref K063713) Gynecare - TVT Secure… | 2003 |
| * | K063713 | Ams Smart Sling SystemSummary page 1…Zippere - bioabsorbable / Non-Absorbable Polymer Sling & Mesh (Ref: K030631) AMS-Smart Sling System & pelvic Floor Repair System (Ref K063713) Gynecare - TVT Secure System & Pelvic Floor Repair System ( K052401) Device Description: The MiniSling TM-… | 2007 |
| * | K052401 | Gynecare TVT Secur SystemSummary page 1…1) AMS-Smart Sling System & pelvic Floor Repair System (Ref K063713) Gynecare - TVT Secure System & Pelvic Floor Repair System ( K052401) Device Description: The MiniSling TM- Adjustable Polymer Sling & Surgical Mesh with Modular Anchor System is available with Si… | 2005 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 1 of the 14 ancestors has a recall of any class.
- 4 other devices also cite its predicate K010533.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MiniSling TM- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroenterological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070846: Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070846
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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