510(k) · Cleared
ClearedDisposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · GDW Staple, Implantable
Cleared on Nov 17, 2016 as substantially equivalent to K131511 (Changzhou Sinolinks Medical Innovation Co., Ltd., 2013) and 1 other predicate after a 129-day review. Its family tree reaches back 7 generations to 1994. 6 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 17, 2016
- Review
- 129 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K940967 (1994). 25 ancestors in all, the oldest K801590 (1980). No later device cites it as a predicate yet. 6 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · Recalled (Class I)
- 6 generations backK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
- 5 generations backK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
- 4 generations backK030925 Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- 3 generations backK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
- 2 generations backK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
- 1 generation backK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
- This deviceK161905 Disposable Circular Stapler for Hemorrhoids, Disposable Circular…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2016
Class I recalls in this family
- K081146 Echelon Endoscopic Linear Cutters (Articulating…2 generations back · 2008
- K051301 Proximate PPH Hemorrhoidal Circular Stapler and…3 generations back · 2005
- K030925 Proximate HCS Hemorrhoidal Circular Stapler and…3 generations back · 2003
- K991030 Proximate HCS Hemorrhoidal Circular Stapler and…3 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | Class I |
| −6 | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | Class I |
| −5 | K991030 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery, Inc. | 1999 | Class I |
| −4 | K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01 | Ethicon Endo-Surgery, Inc. | 2003 | Class I |
| −3 | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS… | Frankenman International Limited | 2009 | — |
| −2 | K120179 | Reach Surgical Staplers | Reach Surgical, Inc. | 2012 | — |
| −1 | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable… | Changzhou Sinolinks Medical Innovation Co., Ltd. | 2013 | — |
| 0 (this device) | K161905 | Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler… | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2016 | — |
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 |
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 15.0 · 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 |
|---|---|---|---|
| * | K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Summary page 6…excess of compressed mucosa. The device is available in 34mm with 4.6mm staple. 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K131511 Product Name: Disposable Circular Stapler Disposable Linear Staplers and Reloads… | 2013 |
| * | K120179 | Reach Surgical StaplersSummary page 6…s Disposable Hemorrhoidal Stapler Disposable Linear Cutter Staplers and Reloads Predicate Device 2 510(k) Number: K120179 Product Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K051301Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 2005 · 3 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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 5 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 22 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 9 of the 25 ancestors have a recall of any class; 6 have a Class I recall.
- 3 other devices also cite its predicate K131511.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries. The Disposable Linear Stapler has application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and…
Read the full statement (118 words)
The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Linear Stapler has application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance and biliary structures.
The Disposable Linear Cutter Stapler and Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161905: Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161905
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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