510(k) · Cleared
ClearedEEA Circular Stapler with Tri-Staple Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GDW Staple, Implantable
Cleared on Apr 29, 2022 as substantially equivalent to K202507 (Covidien, 2021) and 2 other predicates after a 24-day review. Its family tree reaches back 5 generations to 2003. 4 later devices descend from it.
- Decided
- Apr 29, 2022
- Review
- 24 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K024275 (2003). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK024275 Auto Suture Premium Plus Ceea Disposable StaplerUnited States Surgical, A Division of Tyco Healthc · 2003
- 4 generations backK062850 Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
- 3 generations backK172361 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2018 · Recalled
- 2 generations backK192330 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2020
- 1 generation backK202507 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2021
- This deviceK221005 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022
- Descendant · cites it directly · 2 of its ownK221771 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022
- Descendant · 2 generations on · 0 of its ownK253527 Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)…Covidien, LLC · 2026
- Descendant · cites it directly · 0 of its ownK232126 EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™…Covidien · 2023
- Descendant · cites it directly · 0 of its ownK221003 Autosuture EEA Stapler / circular stapler with DST Series Technology…Covidien · 2022
Most influential descendants
Showing 4 of 4 · See all- K221771EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022 · cites it directly2descendants
- K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0…Covidien, LLC · 2026 · 2 generations on0descendants
- K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler…Covidien · 2023 · cites it directly0descendants
- K221003Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture…Covidien · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K024275 | Auto Suture Premium Plus Ceea Disposable Stapler | United States Surgical, A Division of Tyco Healthc | 2003 | — |
| −4 | K062850 | Autosuture Circular Eea Surgical Staplers | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| −3 | K172361 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2018 | 1 |
| −2 | K192330 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| −1 | K202507 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2021 | — |
| 0 (this device) | K221005 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| +1 | K221771 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| +2 | K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)… | Covidien, LLC | 2026 | — |
| +1 | K232126 | EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular… | Covidien | 2023 | — |
| +1 | K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA… | Covidien | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K202507 | EEA Circular Stapler with Tri-Staple TechnologySummary page 4…T, TRIEEAXL31XT, TRIEEA33MT, TRIEEA33XT, TRIEEAXL33MT, TRIEEAXL33XT 510(k) Number: K202507 (Primary Predicate Device) K192330, K172361 Classification Name: Staple, Implantab… | 2021 |
| * | K192330 | EEA Circular Stapler with Tri-Staple TechnologySummary page 4…33XT, TRIEEAXL33MT, TRIEEAXL33XT 510(k) Number: K202507 (Primary Predicate Device) K192330, K172361 Classification Name: Staple, Implantable Regulations Number: 21 CFR 878.4750 Product Codes:… | 2020 |
| * | K172361 | EEA Circular Stapler with Tri-Staple TechnologySummary page 4…EEAXL33MT, TRIEEAXL33XT 510(k) Number: K202507 (Primary Predicate Device) K192330, K172361 Classification Name: Staple, Implantable Regulations Number: 21 CFR 878.4750 Product Codes:… | 2018 |
What descends from it? (4)
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 19 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K221771 (Covidien, 2022) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K202507.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The EEAm circular stapler with Tri-Staplem technology has application throughout the alimentary tract for the creation
of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221005 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221005: EEA Circular Stapler with Tri-Staple Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221005
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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