510(k) · Cleared
ClearedDisposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Kangdi Medical Stapler Co., Ltd. · GDW Staple, Implantable
Cleared on Apr 30, 2010 as substantially equivalent to K920752 (ETHICON, Inc., 1992) after a 46-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Apr 30, 2010
- Review
- 46 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920752 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK920752 Endopath Ils Endoscopic Circular StaplerETHICON, Inc. · 1992
- This deviceK100723 Disposable Circular Stapler, Disposable Circular Stapler Model…Changzhou Kangdi Medical Stapler Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK182217 Linear Cutter Staplers and Loading Units for Single Use, Circular…Ezisurg (Suzhou) Medical Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK181657 easyLCTM Linear Cutter Staplers and Loading Units fot Single Use…Ezisurg Medical Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK172561 Disposable Circular StaplerChangzhou Kangdi Medical Stapler Co., Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K182217Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single UseEzisurg (Suzhou) Medical Co., Ltd. · 2019 · cites it directly0descendants
- K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular…Ezisurg Medical Co., Ltd. · 2019 · cites it directly0descendants
- K172561Disposable Circular StaplerChangzhou Kangdi Medical Stapler Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920752 | Endopath Ils Endoscopic Circular Stapler | ETHICON, Inc. | 1992 | — |
| 0 (this device) | K100723 | Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5… | Changzhou Kangdi Medical Stapler Co., Ltd. | 2010 | — |
| +1 | K182217 | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for… | Ezisurg (Suzhou) Medical Co., Ltd. | 2019 | — |
| +1 | K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM… | Ezisurg Medical Co., Ltd. | 2019 | — |
| +1 | K172561 | Disposable Circular Stapler | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 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 15.0 · 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? (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 |
|---|---|---|---|
| * | K920752 | Endopath Ils Endoscopic Circular StaplerSummary page 1…ame :Staple, implantable Predicate Devices: Manufacturer Device Name 510(k) Number Ethicon Endo- Endopath ILS Endoscopic K920752 Surgery, Inc. Circular Stapler 25mm, 29mm… | 1992 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Disposable Circular Stapler has application throughout the alimentary tract 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/K100723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100723: Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100723
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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