510(k) · Cleared
ClearedSuture Welding System and Kit (SWK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axya Medical, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Nov 27, 1998 as substantially equivalent to K980988 (Axya Medical, Inc., 1998) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Nov 27, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932591 (1993). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK932591 Endo-JudgeSynergistic Medical Technologies, Inc. · 1993
- 1 generation backK980988 Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 1998
- This deviceK983108 Suture Welding System and Kit (SWK)Axya Medical, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK992405 Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK070253 Axya Suture Welding System and KitAxya Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK994313 Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc. · 2000
Most influential descendants
Showing 3 of 3 · See all- K992405Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc. · 1999 · cites it directly1descendant
- K070253Axya Suture Welding System and KitAxya Medical, Inc. · 2007 · cites it directly0descendants
- K994313Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932591 | Endo-Judge | Synergistic Medical Technologies, Inc. | 1993 | — |
| −1 | K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) | Axya Medical, Inc. | 1998 | — |
| 0 (this device) | K983108 | Suture Welding System and Kit (SWK) | Axya Medical, Inc. | 1998 | — |
| +1 | K992405 | Axya Medical Inc, Bone Anchor System and Kit- (Bak) | Axya Medical, Inc. | 1999 | — |
| +1 | K070253 | Axya Suture Welding System and Kit | Axya Medical, Inc. | 2007 | — |
| +1 | K994313 | Modification to Bone Anchor and Kit (Bak) | Axya Medical, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 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 |
|---|---|---|---|
| * | K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Summary page 1…the position that the Axya Suture Welding System and Kit (SWK) is substantially equivalent in design and function to the Axya Suturing and Ligating System (ASLS) {510(k) K980988] and the Endo-Judge disposable suture placement system developed by Synergistic Medical Technologies and marketed by Ethicon Endo… | 1998 |
| * | K932591 | Endo-JudgeSummary page 1…m (ASLS) {510(k) K980988] and the Endo-Judge disposable suture placement system developed by Synergistic Medical Technologies and marketed by Ethicon Endosurgery [510(k) K932591], and that it is appropriate for its intended application. Suture applicators and suture placement devices which may be used in b… | 1993 |
| † | K895252 | Ultracision Ultrasonic Scalpel | 1989 |
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)
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 5 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K992405 (Axya Medical, Inc., 1999) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K980988.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Suture Welding System and Kit is indicated for securing synthetic monofilament sutures in soft tissues and for securing ligatures of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The SWK is indicated for use in both traditional open surgery and endoscopic surgical procedures.
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/K983108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983108: Suture Welding System and Kit (SWK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983108
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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