510(k) · Cleared
ClearedAxiom Fascial Closure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axiom Technology Partners, LLC · OCW Endoscopic Tissue Approximation Device
Cleared on Dec 30, 2010 after a 38-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Dec 30, 2010
- Review
- 38 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK103412 Axiom Fascial Closure SystemAxiom Technology Partners, LLC · 2010
- Descendant · cites it directly · 5 of its ownK132362 Weck Efx Endo Fascial Closure SystemTeleflexmedical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK160117 AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK253541 EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site…Medical Impact · 2026
- Descendant · 2 generations on · 0 of its ownK213271 MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical · 2023
- Descendant · 3 generations on · 0 of its ownK193652 AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132362Weck Efx Endo Fascial Closure SystemTeleflexmedical, Inc. · 2013 · cites it directly5descendants
- K160117AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. · 2016 · 2 generations on1descendant
- K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…Medical Impact · 2026 · 2 generations on0descendants
- K213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical · 2023 · 2 generations on0descendants
- K193652AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K103412 | Axiom Fascial Closure System | Axiom Technology Partners, LLC | 2010 | — |
| +1 | K132362 | Weck Efx Endo Fascial Closure System | Teleflexmedical, Inc. | 2013 | — |
| +2 | K160117 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2016 | — |
| +2 | K253541 | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing… | Medical Impact | 2026 | — |
| +2 | K213271 | MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical | 2023 | — |
| +3 | K193652 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 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? (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 |
|---|---|---|---|
| * | — | Covidien EndoClose Named without a submission number | |
| * | — | Cooper Surgical Carter-Thomason CloseSure System Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132362 | Weck Efx Endo Fascial Closure System | 2013 | 5 |
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?
- Of its descendants, K132362 (Teleflexmedical, Inc., 2013) has gone furthest, with 5 descendants of its own.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Axiom Fascial Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103412: Axiom Fascial Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103412
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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