510(k) · Cleared
ClearedSingle Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Victor Medical Instruments Co., Ltd. · GDW Staple, Implantable
Cleared on Dec 5, 2016 as substantially equivalent to K131511 (Changzhou Sinolinks Medical Innovation Co., Ltd., 2013) and 1 other predicate after a 161-day review. Its family tree reaches back 11 generations to 1985. 6 of the 65 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Dec 5, 2016
- Review
- 161 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K842066 (1985). 61 ancestors in all, the oldest K801590 (1980). 3 later devices descend from it, 3 citing it directly. 6 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 7 generations between
- 3 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 2 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 1 generation backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- This deviceK161757 Single Use Curved Cutters, Single Use Circular Staplers, Single Use…Victor Medical Instruments Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK211197 Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK211811 Disposable Endoscopic Staplers and Reload Unit, Disposable…Wuxi Beien Surgery Device Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK211458 Disposable Anorectal Staplers, Disposable Intraluminal Staplers…Ningbo Verykind Medical Device Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 10 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 8 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 7 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 6 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 5 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 4 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 3 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 2 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 1 generation backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- This deviceK161757 Single Use Curved Cutters, Single Use Circular Staplers, Single Use…Victor Medical Instruments Co., Ltd. · 2016
Class I recalls in this family
- K081146 Echelon Endoscopic Linear Cutters (Articulating…3 generations back · 2008
- K051301 Proximate PPH Hemorrhoidal Circular Stapler and…4 generations back · 2005
- K030925 Proximate HCS Hemorrhoidal Circular Stapler and…4 generations back · 2003
- K991030 Proximate HCS Hemorrhoidal Circular Stapler and…4 generations back · 1999
Most influential descendants
Showing 3 of 3 · See all- K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd. · 2023 · cites it directly0descendants
- K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd. · 2022 · cites it directly0descendants
- K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −10 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −8 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −7 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −6 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −5 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −4 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −3 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| −2 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
| −1 | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA… | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 73 |
| 0 (this device) | K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear… | Victor Medical Instruments Co., Ltd. | 2016 | — |
| +1 | K211197 | Disposable Endoscopic Cutter Stapler and Cartridge | Changzhou Waston Medical Appliance Co., Ltd. | 2023 | — |
| +1 | K211811 | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter… | Wuxi Beien Surgery Device Co., Ltd. | 2022 | — |
| +1 | K211458 | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable… | Ningbo Verykind Medical Device Co., Ltd. | 2021 | — |
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 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 1 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 1 |
| 1999 | 2 | 1 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2004 | 2 | 0 |
| 2005 | 2 | 1 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 1 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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…, 34mm two specifications. The staple size is 4.0mm. It cannot be reloaded. 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K131511 3 / 10 === Page 7 ==… | 2013 |
| * | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Summary page 7…r Disposable Linear Cutter Staplers and Reloads Disposable Curved Cutter Stapler Predicate Device 2 510(k) Number: K111825 Product Name: Endo GIATM Staplers 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify tha… | 2011 |
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? (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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K051301Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 2005 · 4 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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 4 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 6 generations back · ◆ in the 1994 ancestors bar of 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 31 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 16 of the 61 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K211197 (Changzhou Waston Medical Appliance Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 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 Single Use Endoscopic Linear Cutters and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. The Single Use Curved Cutters are intended for transection, resection, and/or creation of anastomoses. The…
Read the full statement (166 words)
The Single Use Endoscopic Linear Cutters and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The Single Use Curved Cutters are intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
The Single Use Circular staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in abdominal or thoracic surgeries.
The Single Use Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Single Use Linear Cutters and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161757: Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161757
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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