510(k) · Cleared
ClearedDeknatel Gwathmey Vascular Stapling Kit (Tenative)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Thoracic Systems · GDW Staple, Implantable
Cleared on Nov 5, 1986 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 5, 1986
- Review
- 14 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK864146 Deknatel Gwathmey Vascular Stapling Kit (Tenative)Cardio Thoracic Systems · 1986
- Descendant · cites it directly · 2 of its ownK011589 Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064…Bypass, Ltd. · 2001
- Descendant · 2 generations on · 1 of its ownK020470 Modification to Corlink Automated Anastomotic DeviceBypass, Ltd. · 2002
- Descendant · 3 generations on · 0 of its ownK033979 Corlink Automated Anastomotic SystemBy-Pass Makafim, Ltd. · 2004
Most influential descendants
Showing 3 of 3 · See all- K011589Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to…Bypass, Ltd. · 2001 · cites it directly2descendants
- K020470Modification to Corlink Automated Anastomotic DeviceBypass, Ltd. · 2002 · 2 generations on1descendant
- K033979Corlink Automated Anastomotic SystemBy-Pass Makafim, Ltd. · 2004 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864146 | Deknatel Gwathmey Vascular Stapling Kit (Tenative) | Cardio Thoracic Systems | 1986 | — |
| +1 | K011589 | Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad… | Bypass, Ltd. | 2001 | — |
| +2 | K020470 | Modification to Corlink Automated Anastomotic Device | Bypass, Ltd. | 2002 | — |
| +3 | K033979 | Corlink Automated Anastomotic System | By-Pass Makafim, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GDW? 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 GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011589 | Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to… | 2001 | 2 |
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, K011589 (Bypass, Ltd., 2001) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, 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 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
https://510kreport.com/device/K864146 · printed Nov 5, 2026
Cite this page
510(k) Report. “K864146: Deknatel Gwathmey Vascular Stapling Kit (Tenative).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K864146
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026