510(k) · Cleared
Recalled · Class II · 2025ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery · GDW Staple, Implantable
Cleared on Mar 15, 2023 as substantially equivalent to K020779 (Ethicon Endo-Surgery, Inc., 2002) after a 90-day review. Its family tree reaches back 3 generations to 1982. It has been recalled once.
- Decided
- Mar 15, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K821994 (1982). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
- 2 generations backK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
- 1 generation backK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
- This deviceK223760 ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter…Ethicon Endo-Surgery · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K821994 | Disposable Linear Stapler-(LSR) | ETHICON, Inc. | 1982 | — |
| −2 | K980023 | Endopath and Proximate Linear Cutters | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −1 | K020779 | Proximate and Endopath Linear Cutters and Staplers | Ethicon Endo-Surgery, Inc. | 2002 | 17 |
| 0 (this device) | K223760 | ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter… | Ethicon Endo-Surgery | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K020779 | Proximate and Endopath Linear Cutters and StaplersSummary page 4…. PREDICATE DEVICES Predicate Device Predicate Device Name Predicate Device Product Codes 510(k) Number K020779 PROXIMATE® Linear Cutters with Safety Devices: TLC55, TLC75, TLC10 Lockout and… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2025 | Class II | Z-0147-2026 | Under Investigation by firm | The devices were shipped unsterilized. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 3 companies; a new generation was cleared every 15.6 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 19 other devices also cite its predicate K020779.
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 ECHELON LINEAR™ Cutters have application in gastrointestinal, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223760 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223760: ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223760
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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