# K020779: Proximate and Endopath Linear Cutters and Staplers

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Jun 5, 2002 after 86 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K821994 (1982). 16 ancestors in all.
87 later devices descend from it; 20 cite it directly.
1 of 104 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821994: Disposable Linear Stapler-(LSR), ETHICON, Inc. (1982) Summary page 1.
- K843034: Disposable Linear Cutter, ETHICON, Inc. (1984) Summary page 1.
- K892927: Proximate Linear Cutter Thick Tissue Inst., ETHICON, Inc. (1989) Summary page 1.
- K932434: Proximate Articulating Linear Stapler, Ethicon Endo-Surgery, Inc. (1994) Summary page 1.
- K935064: Endopath Endoscopic Linear Cutter Modification, ETHICON, Inc. (1994) Summary page 1.
- K961390: Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter, Ethicon Endo-Surgery, Inc. (1996) Summary page 1.
- K970720: Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic Linear Stapler, Ethicon Endo-Surgery, Inc. (1997) Summary page 1.
- K980023: Endopath and Proximate Linear Cutters, Ethicon Endo-Surgery, Inc. (1998) Summary page 1.
- K980815: Endopath EZ45 Endoscopic Linear Cutter, Ethicon Endo-Surgery, Inc. (1998) Summary page 1.
- K002398: Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets Compact-FLEX45 NO-Knife Articulating, Ethicon Endo-Surgery, Inc. (2000) Summary page 1.
- K913802: Auto Suture (R) Powered Endoscopic Gia (TM) Stapler, United States Surgical, A Division of Tyco Healthc (1991) Summary page 1.

## Cited in the summary but 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

## Most influential descendants
- K030653: Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading Units with Reloads (2003), 46 descendants of its own
- K040398: Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads (2004), 45 descendants of its own
- K040720: Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM (2004), 25 descendants of its own
- K071708: I45, I45S, I60, and I60S (2007), 21 descendants of its own
- K093679: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide  Model Various LAA0 (2010), 18 descendants of its own

## Recalls of this device
- Jul 29, 2011 · Not classified · Z-3187-2011: 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 bl
- Mar 27, 2009 · Not classified · Z-1068-2011: 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 a
- Jan 13, 2009 · Not classified · Z-0361-2011: 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 devic
- Apr 24, 2008 · Not classified · Z-2163-2008: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: A defective articulation band may result in improper staple formation with possible hematosis.
- Nov 25, 2003 · Not classified · Z-0213-04: A defective articulation band may result in improper staple formation with possible hematosis.
- May 21, 2003 · Not classified · Z-0986-03: The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
- May 21, 2003 · Not classified · Z-0985-03: The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.

## Indications for use
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.

Source page: https://510kreport.com/device/K020779
Methodology: https://510kreport.com/methodology