510(k) · Cleared
Recalled · 2011Proximate and Endopath Linear Cutters and Staplers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · GDW Staple, Implantable
Cleared on Jun 5, 2002 as substantially equivalent to K821994 (ETHICON, Inc., 1982) and 10 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1982. 1 of the 104 devices in its family, counting itself, has a Class I recall. 87 later devices descend from it. It has been recalled 17 times.
- Decided
- Jun 5, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- GDW
- Recalls
- 17
- Predicates
- 12
Its longest line of descent runs back 2 generations to K821994 (1982). 16 ancestors in all. 87 later devices descend from it, 20 citing it directly. 1 of the 104 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
- 1 generation backK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
- This deviceK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002
- Descendant · cites it directly · 46 of its ownK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- Descendant · 2 generations on · 45 of its ownK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- Descendant · 3 generations on · 25 of its ownK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 21 of its ownK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141952 Echelon Flex Powered Vascular Stapler with…cites it directly · 2014
Most influential descendants
Showing 5 of 87 · See all- K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc. · 2003 · cites it directly46descendants
- K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004 · 2 generations on45descendants
- K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc. · 2004 · 3 generations on25descendants
- K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · 4 generations on21descendants
- K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc. · 2010 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K821994 | Disposable Linear Stapler-(LSR) | ETHICON, Inc. | 1982 | — |
| −1 | K980023 | Endopath and Proximate Linear Cutters | Ethicon Endo-Surgery, Inc. | 1998 | — |
| 0 (this device) | K020779 | Proximate and Endopath Linear Cutters and Staplers | Ethicon Endo-Surgery, Inc. | 2002 | — |
| +1 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| +2 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| +3 | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | 1 |
| +4 | K071708 | I45, I45S, I60, and I60S | Power Medical Interventions, Inc. | 2007 | 1 |
| +3 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 1 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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.
1 device in this family has 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? (12)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K821994 | Disposable Linear Stapler-(LSR)Summary page 1…scope and Accessories, Implantable Staples, General & Plastic SwerY Predicate Devices: ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and… | 1982 |
| * | K843034 | Disposable Linear CutterSummary page 1…Accessories, Implantable Staples, General & Plastic SwerY Predicate Devices: ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA… | 1984 |
| Kept off the family tree | K590841 | ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K892927 | Proximate Linear Cutter Thick Tissue Inst.Summary page 1…taples, General & Plastic SwerY Predicate Devices: ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Su… | 1989 |
| * | K932434 | Proximate Articulating Linear StaplerSummary page 1…eneral & Plastic SwerY Predicate Devices: ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Surgical Co… | 1994 |
| * | K935064 | Endopath Endoscopic Linear Cutter ModificationSummary page 1…Plastic SwerY Predicate Devices: ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Surgical Corporation… | 1994 |
| * | K961390 | Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic CutterSummary page 1…werY Predicate Devices: ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Surgical Corporation) cleared… | 1996 |
| * | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic Linear…Summary page 1…dicate Devices: ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Surgical Corporation) cleared under K9… | 1997 |
| * | K980023 | Endopath and Proximate Linear CuttersSummary page 1…vices: ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Surgical Corporation) cleared under K9 13802.… | 1998 |
| * | K980815 | Endopath EZ45 Endoscopic Linear CutterSummary page 1…NDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Surgical Corporation) cleared under K9 13802. Device De… | 1998 |
| * | K002398 | Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets…Summary page 1…nd PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, KS90841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Surgical Corporation) cleared under K9 13802. Device Description… | 2000 |
| * | K913802 | Auto Suture (R) Powered Endoscopic Gia (TM) StaplerSummary page 1…892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto SutureTMEND0 GIA II and END0 GIA Universal (United States Surgical Corporation) cleared under K9 13802. Device Description: The ENDOPATH and PROXIMATE Linear Cutter models are sterile single use instruments that deliver staples wh… | 1991 |
What descends from it? (87)
See all 8720 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading… | 2003 | 46 |
| K040832 | C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050 | 2005 | 7 |
| K033324 | Compression Anastomosis Clip (Cac) | 2004 | 7 |
| K041751 | Compression Anastomosis Clip (Cac) | 2004 | 6 |
| K111111 | Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic… | 2011 | 5 |
| K141952 | Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon… Class I | 2014 | 4 |
| K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple… | 2014 | 3 |
| K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient… | 2017 | 1 |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter… | 2016 | 1 |
| K121474 | Disposable Linear Stapler, Disposable Linear Cutter | 2012 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2011 | Not classified | Z-3187-2011 | Packaging | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the… |
| Mar 27, 2009 | Not classified | Z-1068-2011 | Other | The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft… |
| Jan 13, 2009 | Not classified | Z-0361-2011 | Other | The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. If the jaws of the device remain clamped down on the tissue… |
| Apr 24, 2008 | Not classified | Z-2163-2008 | Other | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| Apr 24, 2008 | Not classified | Z-2161-2008 | Other | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| Apr 24, 2008 | Not classified | Z-2162-2008 | Other | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| Apr 24, 2008 | Not classified | Z-2164-2008 | Other | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| Nov 21, 2004 | Not classified | Z-0457-05 | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. |
| Nov 21, 2004 | Not classified | Z-0458-05 | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. |
| Nov 21, 2004 | Not classified | Z-0460-05 | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. |
| Nov 21, 2004 | Not classified | Z-0461-05 | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. |
| Nov 21, 2004 | Not classified | Z-0462-05 | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. |
| Nov 21, 2004 | Not classified | Z-0459-05 | Other | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. |
| Nov 25, 2003 | Not classified | Z-0212-04 | Nonconforming Material/Component | A defective articulation band may result in improper staple formation with possible hematosis. |
| Nov 25, 2003 | Not classified | Z-0213-04 | Nonconforming Material/Component | A defective articulation band may result in improper staple formation with possible hematosis. |
| May 21, 2003 | Not classified | Z-0986-03 | Other | The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly. |
| May 21, 2003 | Not classified | Z-0985-03 | Other | The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly. |
The 5 latest of 17 recalls; the web page lists all.
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.
- K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 15.6 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K030653 (Power Medical Interventions, Inc., 2003) has gone furthest, with 46 descendants of its own.
- 2 other devices also cite its predicate K821994.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ENDOPATH ETS Endoscopic Linear Cutter and ETS FLEX Endoscopic Articulating Linear Cutter have application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. The ENDOPATH, ETS45 Endoscopic Linear Cutters, the ETS Flex45 Endoscopic Articulating Linear Cutters, the ETS Compact Flex45 Articulating Linear Cutters are intended for transection, resection, and/or creation of anastomoses. The…
Read the full statement (422 words)
The ENDOPATH ETS Endoscopic Linear Cutter and ETS FLEX Endoscopic Articulating Linear Cutter have application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
The ENDOPATH, ETS45 Endoscopic Linear Cutters, the ETS Flex45 Endoscopic Articulating Linear Cutters, the ETS Compact Flex45 Articulating Linear Cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ENDOPATH ETS Flex45 No-Knife Articulating Linear Staplers and the ETS Compact Flex45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, resection, and/or creation of anastomoses, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The ENDOPATH E245 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection and resection, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic and other minimally invasive surgical procedures for transection, resection, and/or creation of anastomoses, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The PROXIMATE ACCESS 55 Articulating Linear Staplers have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection and resection of tissues.
The PROXIMATE Linear and Vascular Linear Cutters with Safety Lockout 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 PROXIMATE Linear Four Row Stapler with Safety Lockout have application in gastrointestinal and thoracic surgery for transection and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The PROXIMATE Reloadable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
The PROXIMATE Reloadable Vascular Linear Stapler has application for use on internal tissue that can easily be compressed to 1.0 mm in thickness. The staplers may also be used to ligate pulmonary vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020779: Proximate and Endopath Linear Cutters and Staplers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020779
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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