510(k) · Cleared
ClearedEEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GAG Stapler, Surgical
Cleared on Aug 16, 2023 as substantially equivalent to K221771 (Covidien, 2022) and 1 other predicate after a 30-day review. Its family tree reaches back 7 generations to 2003.
- Decided
- Aug 16, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- GAG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K024275 (2003). No later device cites it as a predicate yet.
- Root · 7 generations backK024275 Auto Suture Premium Plus Ceea Disposable StaplerUnited States Surgical, A Division of Tyco Healthc · 2003
- 6 generations backK062850 Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
- 5 generations backK172361 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2018 · Recalled
- 4 generations backK192330 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2020
- 3 generations backK202507 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2021
- 2 generations backK221005 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022
- 1 generation backK221771 EEA Circular Stapler with Tri-Staple TechnologyCovidien · 2022
- This deviceK232126 EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™…Covidien · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K024275 | Auto Suture Premium Plus Ceea Disposable Stapler | United States Surgical, A Division of Tyco Healthc | 2003 | — |
| −6 | K062850 | Autosuture Circular Eea Surgical Staplers | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| −5 | K172361 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2018 | 1 |
| −4 | K192330 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2020 | — |
| −3 | K202507 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2021 | — |
| −2 | K221005 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| −1 | K221771 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022 | — |
| 0 (this device) | K232126 | EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular… | Covidien | 2023 | — |
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 GAG? 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 GAG device
- #1 K241629 ECHELON 3000 45mm Compact Stapler (ECH45C)…score 15.7 · 8 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 |
|---|---|---|---|
| * | K221771 | EEA Circular Stapler with Tri-Staple TechnologySummary page 4…with implantable staples Predicate Device: Proprietary/Trade Name: EEATM Circular Stapler with Tri-StapleTM Technology 510(k) Number: K221771, K221005 Classification Name: Stapler, Surgical and Staple, Implantable Regulations Number: 21 C… | 2022 |
| * | K221005 | EEA Circular Stapler with Tri-Staple TechnologySummary page 4…antable staples Predicate Device: Proprietary/Trade Name: EEATM Circular Stapler with Tri-StapleTM Technology 510(k) Number: K221771, K221005 Classification Name: Stapler, Surgical and Staple, Implantable Regulations Number: 21 CFR 878.47… | 2022 |
| † | K093402 | Autosuture Eea Orvil | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K221771.
How does its category compare?
All GAG devicesGAG Stapler, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GAG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAG
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAG
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAG
1,065in 2025
MAUDE reports naming product code GAG, 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 | 0 | — | 0 | 919 |
| 2008 | 0 | — | 0 | 366 |
| 2009 | 0 | — | 0 | 18 |
| 2010 | 0 | — | 1 | 22 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 1 | 49 |
| 2013 | 0 | — | 0 | 135 |
| 2014 | 0 | — | 0 | 302 |
| 2015 | 0 | — | 0 | 144 |
| 2016 | 0 | — | 0 | 75 |
| 2017 | 0 | — | 0 | 96 |
| 2018 | 0 | — | 1 | 81 |
| 2019 | 0 | — | 0 | 70 |
| 2020 | 0 | — | 0 | 47 |
| 2021 | 0 | — | 0 | 53 |
| 2022 | 1 | — | 0 | 50 |
| 2023 | 4 | 102 | 0 | 109 |
| 2024 | 3 | 138 | 0 | 1,126 |
| 2025 | 2 | — | 0 | 1,065 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EEA™ Circular Stapler with Tri‐Staple™ Technology and OrVil™ transoral circular stapler anvil have 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/K232126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232126: EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232126
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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