# K980023: Endopath and Proximate Linear Cutters - Pathway: 510(k) (Traditional) - Applicant: Ethicon Endo-Surgery, Inc. - Decided: Mar 18, 1998 after 72 days - Product code: GCJ (Laparoscope, General & Plastic Surgery) - Device class: 2 - Regulation: 21 CFR 876.1500 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K821994 (1982). 11 ancestors in all. 88 later devices descend from it; 2 cite it directly. 1 of 100 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. - K915099: Endopath Endos Linear Cut W/Saf Lock-Out/Reload UN, ETHICON, Inc. (1992) Summary page 1. - K930934: Endopath Reloadable Linear Cutter, ETHICON, Inc. (1994) Summary page 1. - K935064: Endopath Endoscopic Linear Cutter Modification, ETHICON, Inc. (1994) Summary page 1. - K945202: Endopath Endoscopic Reloadable Linear Cutter with Safety Loc-Out and Reloading Unit, Ethicon Endo-Surgery, Inc. (1995) Summary page 1. - K951546: Endopath and Proximate Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (1995) Summary page 2. - K961264: Endopath EZ-RF Linear Cutter and Coagulation, Ethicon Endo-Surgery, Inc. (1996) Summary page 2. - K961390: Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter, Ethicon Endo-Surgery, Inc. (1996) Summary page 2. - K970720: Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic Linear Stapler, Ethicon Endo-Surgery, Inc. (1997) Summary page 2. ## Most influential descendants - K020779: Proximate and Endopath Linear Cutters and Staplers (2002), 87 descendants of its own - 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 ## Indications for use K821994: The Disposable Linear Stapler has application in abdominal, thoracic, and pediatric surgery for resection and transection of internal tissues. The total thickness of the tissues being connected must be within the range of 1.0 to 3.0 mm. K843034: The PLC50 has application in abdominal, pediatric and thoracic surgery for resection, transection and creation of anastomoses. K892927: The LCT75 has application in gastrointestinal and thoracic surgery for resection, transection and creation of anastomoses. Cartridges for the standard (PLC75) and Thick Tissue (LCT75) are interchangeable within these instruments. K915099: The ENDOPATH Endoscopic Linear Cutter with Safety Lock-out has applications multiple open or endoscopic procedures for the transection, resection and creation of anastomosis. K930934: The ENDOPATH Endoscopic Reloadable Linear Cutter with Safety Lock-Out has application in gastrointestinal and thoracic surgery for transection, resection and creation of anastomoses. K935064: The ENDOPATH Endoscopic Linear Cutter with Safety Lock-Out has application in multiple open or endoscopic procedures for the transection, resection, and creation of anastomoses. K945202: The ENDOPATH Endoscopic Reloadable Linear-Cutter with Safety Lock-Out has multiple open or endoscopic procedures for transection, resection and/or creation of anastomoses. K951546: [Verbiage for all of the various indication statements remain the same. plus] ... and can be used with staple line or tissue buttressing materials, such as bovine pericardium. K961264: The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications in open and minimally invasive surgical procedures for coagulation, transection, and resection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOM ICC 350 or the Valleylab Force 2 electrosurgical generators. K961390: The ENDOPATH ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. K970720: The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open or 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. and The ENDOPATH EZ45 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 buttressing materials, such as bovine pericardium. Source page: https://510kreport.com/device/K980023 Methodology: https://510kreport.com/methodology