510(k) · Cleared
ClearedIvs Tunneller Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien UK Manufacturing, Ltd. · FTL Mesh, Surgical, Polymeric
Cleared on Mar 5, 2008 as substantially equivalent to K010035 (United States Surgical, A Division of Tyco Healthc, 2001) and 2 other predicates after a 117-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 5, 2008
- Review
- 117 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K915526 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915526 Coated Surgipro (TM) Polypropylene Surgical MeshUnited States Surgical, A Division of Tyco Healthc · 1992 · Recalled
- This deviceK073164 Ivs Tunneller DevicesCovidien UK Manufacturing, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915526 | Coated Surgipro (TM) Polypropylene Surgical Mesh | United States Surgical, A Division of Tyco Healthc | 1992 | 1 |
| 0 (this device) | K073164 | Ivs Tunneller Devices | Covidien UK Manufacturing, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K010035 | Ivs TunnellerSummary page 1…Intra-Vaginal Sling Placement Device CLASSIFICATION NAME: Mesh, Surgical, Polymeric PREDICATE DEVICE(S): IVS Tunneller T M Intra-Vaginal Sling (K010035) Parietene ® Polypropylene Mesh (K991400) Surgipro TM Polypropylene… | 2001 |
| * | K991400 | Parietene Polypropylene MeshSummary page 1…Mesh, Surgical, Polymeric PREDICATE DEVICE(S): IVS Tunneller T M Intra-Vaginal Sling (K010035) Parietene ® Polypropylene Mesh (K991400) Surgipro TM Polypropylene Surgical Mesh (K915526) DEVICE DESCRIPTION: The IVS Tunnell… | 1999 |
| * | K915526 | Coated Surgipro (TM) Polypropylene Surgical MeshSummary page 1…a-Vaginal Sling (K010035) Parietene ® Polypropylene Mesh (K991400) Surgipro TM Polypropylene Surgical Mesh (K915526) DEVICE DESCRIPTION: The IVS TunnellerT M Intra-Vaginal Sling placement device is comp… | 1992 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K010035.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The IVS Tunneller TM Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.
The Obturator IVS TunnellerTM Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI) and for mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073164: Ivs Tunneller Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073164
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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