510(k) · Cleared
ClearedModification to: Abbott Vascular Suture Anastomosis Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Dec 6, 2001 as substantially equivalent to K970793 (United States Surgical, A Division of Tyco Healthc, 1997) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Dec 6, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933887 (1993). 6 ancestors in all, the oldest K771412 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 2 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 1 generation backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- This deviceK013683 Modification to: Abbott Vascular Suture Anastomosis DeviceAbbott Vascular, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK221280 VessealLydus Medical, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221280VessealLydus Medical, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −2 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −1 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| 0 (this device) | K013683 | Modification to: Abbott Vascular Suture Anastomosis Device | Abbott Vascular, Inc. | 2001 | — |
| +1 | K221280 | Vesseal | Lydus Medical, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K970793 | Implantable ClipSummary page 1…, 2001 Abbott Vascular Suture Anastomosis Device Suture Delivery Device Class I Suture, Implantable GAW 1. U.S. Surgical Corporation VCS Anastomotic Clip Cartridge, K970793 2. Coalescent Surgical Sutured-Clip, K994160 3. Deknatel (Genzyme Corporation) Deklene® II Surgical Suture The Abbott Vascular… | 1997 |
| * | K994160 | Coalescent Surgical Sutured-ClipSummary page 1…vice Suture Delivery Device Class I Suture, Implantable GAW 1. U.S. Surgical Corporation VCS Anastomotic Clip Cartridge, K970793 2. Coalescent Surgical Sutured-Clip, K994160 3. Deknatel (Genzyme Corporation) Deklene® II Surgical Suture The Abbott Vascular Suture Anastomosis Device is intended for use… | 2000 |
| * | — | Deknatel (Genzyme Corporation) Deklene® II Surgical Suture Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221280 | Vesseal | 2022 | 0 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K221280 (Lydus Medical, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K970793.
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 Abbott Vascular Suture Anastomosis Device is indicated for use in the delivery of 10 interrupted sutures to assist the surgeon in the creation of vascular anastomoses.
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/K013683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013683: Modification to: Abbott Vascular Suture Anastomosis Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013683
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026