510(k) · Cleared
ClearedSingle Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Golden Stapler Surgical Co., Ltd. · GDW Staple, Implantable
Cleared on Jul 14, 2017 as substantially equivalent to K030411 (Ethicon Endo-Surgery, Inc., 2003) and 5 other predicates after a 289-day review. Its family tree reaches back 11 generations to 1985. 4 of the 64 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jul 14, 2017
- Review
- 289 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K842066 (1985). 62 ancestors in all, the oldest K821994 (1982). 1 later device descends from it, 1 citing it directly. 4 of the 64 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 deviceK162707 Single Use Circular Stapler, Single Use Hemorrhoidal Circular…Golden Stapler Surgical Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK200320 Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus…M/s. Meril Endo Surgery Private Limited. · 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 deviceK162707 Single Use Circular Stapler, Single Use Hemorrhoidal Circular…Golden Stapler Surgical Co., Ltd. · 2017
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited. · 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) | K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single… | Golden Stapler Surgical Co., Ltd. | 2017 | — |
| +1 | K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal… | M/s. Meril Endo Surgery Private Limited. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 1 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 1 |
| 1999 | 2 | 1 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
4 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 15.1 · 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? (6)
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 |
|---|---|---|---|
| * | K030411 | Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03Summary page 7…11 K162707 S001 E2 510(k) Summary Predicate Device 1 510(k) Number: K030411 Product Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories Predicate Device 2 510(k) Number: K98… | 2003 |
| * | K983536 | Proximate Curved and Straight Intraluminal StaplersSummary page 7…dicate Device 1 510(k) Number: K030411 Product Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories Predicate Device 2 510(k) Number: K983536 Product Name: PROXIMATE® Curved and Straight Intraluminal Staplers Predicate Device 3 510(k) Number: K020779… | 1998 |
| * | K020779 | Proximate and Endopath Linear Cutters and StaplersSummary page 7…Predicate Device 2 510(k) Number: K983536 Product Name: PROXIMATE® Curved and Straight Intraluminal Staplers Predicate Device 3 510(k) Number: K020779 Product Name: ENDOPATH and PROXIMATE Linear Cutters and Staplers Predicate Device 4 510(k) Number: K111825… | 2002 |
| * | K111825 | Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Summary page 7…Predicate Device 3 510(k) Number: K020779 Product Name: ENDOPATH and PROXIMATE Linear Cutters and Staplers Predicate Device 4 510(k) Number: K111825 Product Name: DST SeriesTM Staplers Predicate Device 5 510(k) Number: K061156 Product Name: ENDOPATH Linear… | 2011 |
| * | K061156 | Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and…Summary page 7…Linear Cutters and Staplers Predicate Device 4 510(k) Number: K111825 Product Name: DST SeriesTM Staplers Predicate Device 5 510(k) Number: K061156 Product Name: ENDOPATH Linear Cutters and Staplers Predicate Device 6 510(k) Number: K062869 Product Name:… | 2006 |
| * | K062869 | Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GSummary page 7…esTM Staplers Predicate Device 5 510(k) Number: K061156 Product Name: ENDOPATH Linear Cutters and Staplers Predicate Device 6 510(k) Number: K062869 Product Name: CONTOURTM Curved Cutter Stapler and Reloads 6. Identification of Reference Devices Reference Device… | 2007 |
| † | K080839 | Echelon Gray Cartridge, Model ERC45M | 2008 |
| † | K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular… | 2021 | 0 |
Has anything in its family been recalled? (4 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.
- K030411Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03Ethicon Endo-Surgery, Inc. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 112 Class I recalls
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 2 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
- 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 32 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 15 of the 62 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K200320 (M/s. Meril Endo Surgery Private Limited., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K030411.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses. The Single Patient Use Endo Cutter and Reload is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials. The…
Read the full statement (211 words)
The Single Use Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses.
The Single Patient Use Endo Cutter and Reload is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.
The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Single Use Hemorrhodial Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
The Single Patient Use Transverse Cutter and Reload is intended for transection, resection and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162707 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162707: Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162707
Report an extraction error
Are you the manufacturer?
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