510(k) · Cleared
Recalled · Class II · 2018EEA 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 Feb 16, 2018 as substantially equivalent to K062850 (United States Surgical, A Division of Tyco Healthc, 2006) after a 196-day review. Its family tree reaches back 2 generations to 2003. 10 later devices descend from it. It has been recalled once.
- Decided
- Feb 16, 2018
- Review
- 196 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K024275 (2003). 10 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK024275 Auto Suture Premium Plus Ceea Disposable StaplerUnited States Surgical, A Division of Tyco Healthc · 2003
- 1 generation backK062850 Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
- This deviceK172361 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2018
- Descendant · cites it directly · 8 of its ownK192330 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2020
- Descendant · cites it directly · 5 of its ownK202507 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2021
- Descendant · cites it directly · 4 of its ownK221005 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022
- Descendant · cites it directly · 3 of its ownK182475 Signia Circular Adapters (for use with Signia Staplers), Tri-Staple…Covidien · 2019
- Descendant · 2 generations on · 2 of its ownK221629 Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™…Covidien · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K192330EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2020 · cites it directly8descendants
- K202507EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2021 · cites it directly5descendants
- K221005EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022 · cites it directly4descendants
- K182475Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads…Covidien · 2019 · cites it directly3descendants
- K221629Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)Covidien · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K024275 | Auto Suture Premium Plus Ceea Disposable Stapler | United States Surgical, A Division of Tyco Healthc | 2003 | — |
| −1 | K062850 | Autosuture Circular Eea Surgical Staplers | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| 0 (this device) | K172361 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2018 | — |
| +1 | K192330 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| +1 | K202507 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2021 | — |
| +1 | K221005 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| +1 | K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0… | Covidien | 2019 | — |
| +2 | K221629 | Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) | Covidien | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 15.0 · 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? (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 |
|---|---|---|---|
| * | K062850 | Autosuture Circular Eea Surgical StaplersSummary page 4…Surgical Stapler with Implantable Staples Classification Product Code, Regulation: GDW, 21 CFR 878.4750/ GAG, 21 CFR 878.4800 510(k) Number: K062850 Class: II Manufacturer: Covidien Device Description: The EEA'M circular stapler with Tri-Staple™… | 2006 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192330 | EEA Circular Stapler with Tri-Staple Technology | 2020 | 8 |
| K202507 | EEA Circular Stapler with Tri-Staple Technology | 2021 | 5 |
| K221005 | EEA Circular Stapler with Tri-Staple Technology | 2022 | 4 |
| K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads… | 2019 | 3 |
| K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2018 | Class II | Z-0070-2019 | Process design | The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K192330 (Covidien, 2020) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K062850.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 EEA'M circular stapler with Tri-Staple'M 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/K172361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172361: EEA Circular Stapler with Tri-Staple Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172361
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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