510(k) · Cleared
Recalled · Class II · 2018Eea Hemorrhoid Stapler & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Devices, A Global Business Unit Covidien · GDW Staple, Implantable
Cleared on Feb 4, 2009 as substantially equivalent to K062850 (United States Surgical, A Division of Tyco Healthc, 2006) and 1 other predicate after a 47-day review. Its family tree reaches back 2 generations to 2003. 1 of the 4 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times.
- Decided
- Feb 4, 2009
- Review
- 47 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K024275 (2003). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- 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 deviceK083781 Eea Hemorrhoid Stapler & AccessoriesSurgical Devices, A Global Business Unit Covidien · 2009
Class I recalls in this family
- K051301 Proximate PPH Hemorrhoidal Circular Stapler and…direct predicate · 2005
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) | K083781 | Eea Hemorrhoid Stapler & Accessories | Surgical Devices, A Global Business Unit Covidien | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K062850 | Autosuture Circular Eea Surgical StaplersSummary page 1…Surgical Stapler with Implantable Staple CLASSIFICATION NAME: Staple, Implantable PREDICATE DEVICE(S): AutosutureTM DST Series TM EEA TMSurgical Stapler (K062850) Ethicon Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Ac… | 2006 |
| * | K051301 | Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesSummary page 1…A TMSurgical Stapler (K062850) Ethicon Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories (K051301) DEVICE DESCRIPTION: The EEATM Hemorrhoid stapler is designed for use as a stapling instrume… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2018 | Class II | Z-1527-2018 | Nonconforming Material/Component | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. |
| Apr 9, 2018 | Class II | Z-1528-2018 | Nonconforming Material/Component | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K051301Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- 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. 2009, 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 EEATM Hemorrhoid Stapler and accessories has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
The EEATM Hemorrhoid Stapler and accessories can also be used in the lower alimentary tract for the creation of end-to-end and end-to-side anastomosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083781: Eea Hemorrhoid Stapler & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083781
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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