510(k) · Cleared

Cleared

Endopath and Proximate Linear Cutters

K980023510(k) TraditionalCleared Mar 18, 199872-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ethicon Endo-Surgery, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Mar 18, 1998 as substantially equivalent to K821994 (ETHICON, Inc., 1982) and 10 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1982. 1 of the 100 devices in its family, counting itself, has a Class I recall. 88 later devices descend from it.

Decided: Mar 18, 1998
Review: 72 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 11

Its longest line of descent runs back 1 generation to K821994 (1982). 11 ancestors in all. 88 later devices descend from it, 2 citing it directly. 1 of the 100 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
This deviceK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
Descendant · cites it directly · 87 of its ownK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
Descendant · 2 generations on · 46 of its ownK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
Descendant · 3 generations on · 45 of its ownK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
Descendant · 4 generations on · 25 of its ownK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
Descendant · 5 generations on · 21 of its ownK071708 I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · Recalled

Showing 5 of 88 descendants. See all descendants

Descendants cleared per year

2002high 9 (2007) · low 0 (2024)2026

Class I recalls in this family

K141952 Echelon Flex Powered Vascular Stapler with…2 generations on · 2014

Most influential descendants

Showing 5 of 88 · See all

K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · cites it directly87descendants
K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc. · 2003 · 2 generations on46descendants
K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004 · 3 generations on45descendants
K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc. · 2004 · 4 generations on25descendants
K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc. · 2007 · 5 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K821994	Disposable Linear Stapler-(LSR)	ETHICON, Inc.	1982	—
0 (this device)	K980023	Endopath and Proximate Linear Cutters	Ethicon Endo-Surgery, Inc.	1998	—
+1	K020779	Proximate and Endopath Linear Cutters and Staplers	Ethicon Endo-Surgery, Inc.	2002	17
+2	K030653	Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital…	Power Medical Interventions, Inc.	2003	—
+3	K040398	Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads	Power Medical Interventions, Inc.	2004	—
+4	K040720	Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55…	Power Medical Interventions, Inc.	2004	1
+5	K071708	I45, I45S, I60, and I60S	Power Medical Interventions, Inc.	2007	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1989	1	0
1992	1	0
1994	2	0
1995	2	0
1996	2	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
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

FIG. 1 — Lineage of K980023, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (11)

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	Applicant	Decided	Recalls
*	K821994	Disposable Linear Stapler-(LSR) Summary page 1 …fication Name: Endoscope and Accessories Common Name: Linear Cutter Trade Name/Proprietary Name: ENDOPATH® and PROXIMATE® Linear Cutters Linear Stapler (LSR) - Rigid (K821994); Disposable Linear Cutter (K843034); PROXIMATE® Linear Cutter Thick Tissue Instrument (K892927); ENDOPATH® Endoscopic Linear…	ETHICON, Inc.	1982	—
*	K843034	Disposable Linear Cutter Summary page 1 …ies Common Name: Linear Cutter Trade Name/Proprietary Name: ENDOPATH® and PROXIMATE® Linear Cutters Linear Stapler (LSR) - Rigid (K821994); Disposable Linear Cutter (K843034); PROXIMATE® Linear Cutter Thick Tissue Instrument (K892927); ENDOPATH® Endoscopic Linear Cutter with Safety Lock-Out and Reloa…	ETHICON, Inc.	1984	—
*	K892927	Proximate Linear Cutter Thick Tissue Inst. Summary page 1 …ENDOPATH® and PROXIMATE® Linear Cutters Linear Stapler (LSR) - Rigid (K821994); Disposable Linear Cutter (K843034); PROXIMATE® Linear Cutter Thick Tissue Instrument (K892927); ENDOPATH® Endoscopic Linear Cutter with Safety Lock-Out and Reloading Unit (K915099); ENDOPATH® Reloadable Linear Cutter with…	ETHICON, Inc.	1989	—
*	K915099	Endopath Endos Linear Cut W/Saf Lock-Out/Reload UN Summary page 1 …osable Linear Cutter (K843034); PROXIMATE® Linear Cutter Thick Tissue Instrument (K892927); ENDOPATH® Endoscopic Linear Cutter with Safety Lock-Out and Reloading Unit (K915099); ENDOPATH® Reloadable Linear Cutter with Safety Lock-Out and Reloading Unit (K930934); Modified ENDOPATH® Endoscopic Linear Cu…	ETHICON, Inc.	1992	—
*	K930934	Endopath Reloadable Linear Cutter Summary page 1 …927); ENDOPATH® Endoscopic Linear Cutter with Safety Lock-Out and Reloading Unit (K915099); ENDOPATH® Reloadable Linear Cutter with Safety Lock-Out and Reloading Unit (K930934); Modified ENDOPATH® Endoscopic Linear Cutter with Safety Lock-Out and Reloading Unit (No-Row) (K935064), Modified ENDOPATH® En…	ETHICON, Inc.	1994	—
*	K935064	Endopath Endoscopic Linear Cutter Modification Summary page 1 …eloadable Linear Cutter with Safety Lock-Out and Reloading Unit (K930934); Modified ENDOPATH® Endoscopic Linear Cutter with Safety Lock-Out and Reloading Unit (No-Row) (K935064), Modified ENDOPATH® Endoscopic Reloadable Linear Cutter with Safety Lockout and Reload Unit (K945202); Continued on next page…	ETHICON, Inc.	1994	—
*	K945202	Endopath Endoscopic Reloadable Linear Cutter with Safety Loc-Out and Reloading Unit Summary page 1 …ic Linear Cutter with Safety Lock-Out and Reloading Unit (No-Row) (K935064), Modified ENDOPATH® Endoscopic Reloadable Linear Cutter with Safety Lockout and Reload Unit (K945202); Continued on next page ETHICON ENDO-SURGERY, INC. 13 New Contraindication for the ENDOPATH® and PROXIMATE® Linear Cutters =…	Ethicon Endo-Surgery, Inc.	1995	—
*	K951546	Endopath and Proximate Linear Cutters and Staplers Summary page 2 …scription Intended use Indications statement Technological characteristics Performance data New Indication for ENDOPATH® and PROXIMATE® Linear Cutters and Staplers (K951546); ENDOPATH® EZ-RF Linear Cutter and Coagulation Device (K961264); ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopi…	Ethicon Endo-Surgery, Inc.	1995	—
*	K961264	Endopath EZ-RF Linear Cutter and Coagulation Summary page 2 …racteristics Performance data New Indication for ENDOPATH® and PROXIMATE® Linear Cutters and Staplers (K951546); ENDOPATH® EZ-RF Linear Cutter and Coagulation Device (K961264); ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter Devices (K961390); and, ENDOPATH® E…	Ethicon Endo-Surgery, Inc.	1996	—
*	K961390	Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter Summary page 2 …46); ENDOPATH® EZ-RF Linear Cutter and Coagulation Device (K961264); ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter Devices (K961390); and, ENDOPATH® EZ45 Endoscopic Linear Cutter and ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler (K970720). All device func…	Ethicon Endo-Surgery, Inc.	1996	2
*	K970720	Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic Linear… Summary page 2 …nd ETS-FLEX Endoscopic Articulating Linear Cutter Devices (K961390); and, ENDOPATH® EZ45 Endoscopic Linear Cutter and ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler (K970720). All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials…	Ethicon Endo-Surgery, Inc.	1997	—

Also cleared against K821994: 2 other devices →

What descends from it? (88)

See all 88

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020779	Proximate and Endopath Linear Cutters and Staplers	Ethicon Endo-Surgery, Inc.	2002	87
K070859	Reprocessed Ethicon Ets Endoscopic Linear Cutters	Sterilmed, Inc.	2007	0

Has anything in its family been recalled? (1 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.

K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 11 ancestors has a recall of any class.
Of its descendants, K020779 (Ethicon Endo-Surgery, Inc., 2002) has gone furthest, with 87 descendants of its own.
2 other devices also cite its predicate K821994.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

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…

Read the full statement (364 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980023 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980023: Endopath and Proximate Linear Cutters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980023

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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