510(k) · Cleared
ClearedAEON Endoscopic Stapler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lexington Medical, Inc. · GDW Staple, Implantable
Cleared on Apr 21, 2023 as substantially equivalent to K201882 (Lexington Medical, Inc., 2020) after a 270-day review. Its family tree reaches back 11 generations to 1994. 6 of the 32 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Apr 21, 2023
- Review
- 270 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K940967 (1994). 29 ancestors in all, the oldest K801590 (1980). 2 later devices descend from it, 2 citing it directly. 6 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- 7 generations between
- 3 generations backK173443 AEON Endoscopic StaplerLexington Medical, Inc. · 2018
- 2 generations backK182380 AEON Endoscopic StaplerLexington Medical, Inc. · 2018
- 1 generation backK201882 AEON Endoscopic StaplerLexington Medical, Inc. · 2020
- This deviceK222210 AEON Endoscopic StaplerLexington Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251482 AEON™ Endoscopic Powered StaplerLexington Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK234039 AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic…Lexington Medical, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- 10 generations backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
- 9 generations backK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
- 8 generations backK030925 Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- 7 generations backK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
- 6 generations backK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
- 5 generations backK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
- 4 generations backK141367 LS Series Linear Stapler and Reloads, CLC Series Curved Linear…Touchstone International Medical Science Co., Ltd. · 2014
- 3 generations backK173443 AEON Endoscopic StaplerLexington Medical, Inc. · 2018
- 2 generations backK182380 AEON Endoscopic StaplerLexington Medical, Inc. · 2018
- 1 generation backK201882 AEON Endoscopic StaplerLexington Medical, Inc. · 2020
- This deviceK222210 AEON Endoscopic StaplerLexington Medical, Inc. · 2023
Class I recalls in this family
- K081146 Echelon Endoscopic Linear Cutters (Articulating…6 generations back · 2008
- K051301 Proximate PPH Hemorrhoidal Circular Stapler and…7 generations back · 2005
- K030925 Proximate HCS Hemorrhoidal Circular Stapler and…7 generations back · 2003
- K991030 Proximate HCS Hemorrhoidal Circular Stapler and…7 generations back · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | Class I |
| −10 | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | Class I |
| −9 | K991030 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery, Inc. | 1999 | Class I |
| −8 | K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01 | Ethicon Endo-Surgery, Inc. | 2003 | Class I |
| −7 | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS… | Frankenman International Limited | 2009 | — |
| −6 | K120179 | Reach Surgical Staplers | Reach Surgical, Inc. | 2012 | — |
| −5 | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable… | Changzhou Sinolinks Medical Innovation Co., Ltd. | 2013 | — |
| −4 | K141367 | LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and… | Touchstone International Medical Science Co., Ltd. | 2014 | — |
| −3 | K173443 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018 | — |
| −2 | K182380 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018 | — |
| −1 | K201882 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2020 | — |
| 0 (this device) | K222210 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2023 | — |
| +1 | K251482 | AEON™ Endoscopic Powered Stapler | Lexington Medical, Inc. | 2025 | — |
| +1 | K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered… | Lexington Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 1 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 1 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
6 devices in this family have 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 15.1 · 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? (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 |
|---|---|---|---|
| * | K201882 | AEON Endoscopic StaplerSummary page 4…Classification Panel: General & Plastic Surgery Primary Product Code: GAG Secondary Product Code: GDW 5. Predicate Device Identification 510(k) Number: K201882 Product Name: AEON™ Endoscopic Stapler Manufacturer: Lexington Medical Inc. Predicate Device: 510(k) Number: K… | 2020 |
| † | K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH… | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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.
- K081146Echelon Endoscopic Linear Cutters (Articulating and Straight)Ethicon Endo-Surgery, LLC · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K051301Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 2005 · 7 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K030925Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Ethicon Endo-Surgery, Inc. · 2003 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · 8 generations back · ◆ on the line of descent in FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 9 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 9 of the 29 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K251482 (Lexington Medical, Inc., 2025) has gone furthest, with 0 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. 2023, 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 AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may also be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222210 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222210: AEON Endoscopic Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222210
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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