510(k) · Cleared
ClearedLinear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ezisurg (Suzhou) Medical Co., Ltd. · GDW Staple, Implantable
Cleared on Apr 16, 2019 as substantially equivalent to K020779 (Ethicon Endo-Surgery, Inc., 2002) and 2 other predicates after a 244-day review. Its family tree reaches back 3 generations to 1982. 2 of the 22 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 16, 2019
- Review
- 244 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K821994 (1982). 21 ancestors in all. No later device cites it as a predicate yet. 2 of the 22 devices in this family, counting this one, have a Class I recall.
- 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 deviceK182217 Linear Cutter Staplers and Loading Units for Single Use, Circular…Ezisurg (Suzhou) Medical Co., Ltd. · 2019
Class I recalls in this family
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) | K182217 | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for… | Ezisurg (Suzhou) Medical Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 1 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 1 |
| 2000 | 1 | 0 |
| 2010 | 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.
2 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 15.0 · 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? (3)
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 6…(3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K020779 Product Name: ENDOPATHTM and PROXIMATETM Linear Cutters and Staplers Predicate Device 2 510(k) Number: K983536… | 2002 |
| * | K983536 | Proximate Curved and Straight Intraluminal StaplersSummary page 6…Predicate Device 1 510(k) Number: K020779 Product Name: ENDOPATHTM and PROXIMATETM Linear Cutters and Staplers Predicate Device 2 510(k) Number: K983536 Device Name: PROXIMATE Curved and Straight Intraluminal Staplers Predicate Device 3 510(k) Number: K100723… | 1998 |
| * | K100723 | Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5Summary page 6…Predicate Device 2 510(k) Number: K983536 Device Name: PROXIMATE Curved and Straight Intraluminal Staplers Predicate Device 3 510(k) Number: K100723 Device Name: PROXIMATE Curved and Straight Intraluminal Staplers 6. Non-Clinical Test Conclusion Non clinical tes… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 2 generations back · ◆ in the 1994 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 15.6 years on median.
- 4 of the 21 ancestors have a recall of any class; 2 have a Class I recall.
- 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. 2019, 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 Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection,
resection,and/or creation of anastomoses.
The Circular Staplers for Single Use has applications throughout the alimentary for end to end, end to side and side to
side anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182217: Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182217
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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