510(k) · Cleared

Cleared

Proximate Linear Cutter Thick Tissue Inst.

K892927510(k) TraditionalCleared May 26, 198935-day reviewClass II21 CFR 878.4740

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

Cleared on May 26, 1989 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 92 devices in its family, counting itself, has a Class I recall. 91 later devices descend from it.

Decided: May 26, 1989
Review: 35 days
Class: Class II
Product code: GAG
Recalls: None
Predicates: 0

91 later devices descend from it, 4 citing it directly. 1 of the 92 devices in this family, counting this one, has a Class I recall.

This deviceK892927 Proximate Linear Cutter Thick Tissue Inst.ETHICON, Inc. · 1989
Descendant · cites it directly · 88 of its ownK980023 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

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

1998high 9 (2007) · low 0 (1999)2026

Class I recalls in this family

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

Most influential descendants

Showing 5 of 91 · See all

K980023Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998 · cites it directly88descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K892927	Proximate Linear Cutter Thick Tissue Inst.	ETHICON, Inc.	1989	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2003	2	0
2004	6	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 K892927, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 GAG device

#1 K241629 ECHELON 3000 45mm Compact Stapler (ECH45C)…score 15.7 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (91)

See all 91

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

Number	Device	Applicant	Decided	Descendants
K980023	Endopath and Proximate Linear Cutters	Ethicon Endo-Surgery, Inc.	1998	88
K020779	Proximate and Endopath Linear Cutters and Staplers	Ethicon Endo-Surgery, Inc.	2002	87
K042492	Hand STC, Model 60MM	Niti Medical Technologies, Ltd.	2004	0
K032973	Reprocessed Disposable Cutters, Staplers and Appliers	Vanguard Medical Concepts, Inc.	2003	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?

Of its descendants, K980023 (Ethicon Endo-Surgery, Inc., 1998) has gone furthest, with 88 descendants of its own.

How does its category compare?

All GAG devices

GAG Stapler, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAG

2in 2025

2007high 4 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAG

138in 2024

2007high 138 (2024) · low 102 (2023)2026

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

Recalls per year · GAG

1in 2018

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAG

1,065in 2025

2007high 1,126 (2024) · low 18 (2009)2025

MAUDE reports naming product code GAG, 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	0	—	0	919
2008	0	—	0	366
2009	0	—	0	18
2010	0	—	1	22
2011	0	—	0	19
2012	0	—	1	49
2013	0	—	0	135
2014	0	—	0	302
2015	0	—	0	144
2016	0	—	0	75
2017	0	—	0	96
2018	0	—	1	81
2019	0	—	0	70
2020	0	—	0	47
2021	0	—	0	53
2022	1	—	0	50
2023	4	102	0	109
2024	3	138	0	1,126
2025	2	—	0	1,065
2026	1	—	0	—

https://510kreport.com/device/K892927 · printed Nov 4, 2026

Cite this page

510(k) Report. “K892927: Proximate Linear Cutter Thick Tissue Inst..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K892927

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026