510(k) · Cleared
ClearedAxya Suture Welding System and Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axya Medical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jul 11, 2007 as substantially equivalent to K983108 (Axya Medical, Inc., 1998) after a 166-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jul 11, 2007
- Review
- 166 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932591 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK932591 Endo-JudgeSynergistic Medical Technologies, Inc. · 1993
- 2 generations backK980988 Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 1998
- 1 generation backK983108 Suture Welding System and Kit (SWK)Axya Medical, Inc. · 1998
- This deviceK070253 Axya Suture Welding System and KitAxya Medical, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932591 | Endo-Judge | Synergistic Medical Technologies, Inc. | 1993 | — |
| −2 | K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) | Axya Medical, Inc. | 1998 | — |
| −1 | K983108 | Suture Welding System and Kit (SWK) | Axya Medical, Inc. | 1998 | — |
| 0 (this device) | K070253 | Axya Suture Welding System and Kit | Axya Medical, Inc. | 2007 | — |
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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K983108 | Suture Welding System and Kit (SWK)Summary page 1…Product Code: HCF Predicate Devices: Axya Suture Welding System and Kit (SWK) [510(k) Number K983108] Axya Automatic Suturing and Ligating System (ASLS) [510(k) K980988] D… | 1998 |
| † | K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) | 1998 |
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 14 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K983108.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The Axya Suture Welding System is indicated for use in securing sutures in soft tissues and for securing ligatures of tubular structures wherever conventional sutures or surgical staples are appropriate. The System may be used in arthroscopic, laparoscopic and open surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070253: Axya Suture Welding System and Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070253
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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