510(k) · Cleared
ClearedDisposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuxi Beien Surgery Device Co., Ltd. · GDW Staple, Implantable
Cleared on Mar 3, 2022 as substantially equivalent to K120179 (Reach Surgical, Inc., 2012) and 1 other predicate after a 265-day review. Its family tree reaches back 12 generations to 1985. 6 of the 63 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 3, 2022
- Review
- 265 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K842066 (1985). 62 ancestors in all, the oldest K801590 (1980). No later device cites it as a predicate yet. 6 of the 63 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 8 generations between
- 3 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 2 generations backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 1 generation backK161757 Single Use Curved Cutters, Single Use Circular Staplers, Single Use…Victor Medical Instruments Co., Ltd. · 2016
- This deviceK211811 Disposable Endoscopic Staplers and Reload Unit, Disposable…Wuxi Beien Surgery Device Co., Ltd. · 2022
Show all 12 generations
- Root · 12 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 11 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 10 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 9 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 8 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 7 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 6 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 5 generations backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- 4 generations backK080898 Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units…Tyco Healthcare Group LP · 2008 · Recalled
- 3 generations backK103263 Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H · 2010
- 2 generations backK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- 1 generation backK161757 Single Use Curved Cutters, Single Use Circular Staplers, Single Use…Victor Medical Instruments Co., Ltd. · 2016
- This deviceK211811 Disposable Endoscopic Staplers and Reload Unit, Disposable…Wuxi Beien Surgery Device Co., Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −12 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −11 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −10 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −9 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −8 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −7 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −6 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −5 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| −4 | K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with… | Tyco Healthcare Group LP | 2008 | 24 |
| −3 | K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology | Covidien, Formerly US Surgical A Divison of Tyco H | 2010 | — |
| −2 | 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 |
| −1 | K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear… | Victor Medical Instruments Co., Ltd. | 2016 | — |
| 0 (this device) | K211811 | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter… | Wuxi Beien Surgery Device Co., Ltd. | 2022 | — |
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 |
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 |
|---|---|---|---|
| * | K120179 | Reach Surgical StaplersSummary page 6…and 4.8mm. It may be reloaded and fired up to 5 times in a single procedure. 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K120179 Product Name: Circular Staplers with Staples Linear Cutting Staplers with Single Use Loading Units… | 2012 |
| * | K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Summary page 6…Endoscopic Linear Cutting Staplers with Single Use Loading Units Manufacturer: Reach Surgical, Inc. Predicate Device 2 510(k) Number: K161757 Product Name: Single Use Hemorrhoidal Staplers Single Use Endoscopic Linear Cutters and Reloads… | 2016 |
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 · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 5 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 37 years and passes through 9 companies; a new generation was cleared every 2.3 years on median.
- 16 of the 62 ancestors have a recall of any class; 6 have a Class I recall.
- 5 other devices also cite its predicate K120179.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 staplers have application throughout the alimentary tract for end to end, end to side, and side to side anastomoses.
The Disposable Endoscopic Staplers and Reload Unit have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses.
The Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids.
Disposable Linear Cutter Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211811: Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211811
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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