510(k) · Cleared

Cleared

Disposable Linear Stapler (LSF)

K822345510(k) TraditionalCleared Sep 21, 198247-day reviewClass II21 CFR 878.4750

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

ETHICON, Inc. · GDW Staple, Implantable

Cleared on Sep 21, 1982 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided: Sep 21, 1982
Review: 47 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 0

22 later devices descend from it, 2 citing it directly.

This deviceK822345 Disposable Linear Stapler (LSF)ETHICON, Inc. · 1982
Descendant · cites it directly · 21 of its ownK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
Descendant · 2 generations on · 17 of its ownK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
Descendant · 3 generations on · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
Descendant · 3 generations on · 7 of its ownK141367 LS Series Linear Stapler and Reloads, CLC Series Curved Linear…Touchstone International Medical Science Co., Ltd. · 2014
Descendant · 4 generations on · 5 of its ownK173443 AEON Endoscopic StaplerLexington Medical, Inc. · 2018

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2009high 3 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 22 · See all

K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited · 2009 · cites it directly21descendants
K120179Reach Surgical StaplersReach Surgical, Inc. · 2012 · 2 generations on17descendants
K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · 3 generations on14descendants
K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…Touchstone International Medical Science Co., Ltd. · 2014 · 3 generations on7descendants
K173443AEON Endoscopic StaplerLexington Medical, Inc. · 2018 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K822345	Disposable Linear Stapler (LSF)	ETHICON, Inc.	1982	—
+1	K090821	Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS…	Frankenman International Limited	2009	—
+2	K120179	Reach Surgical Staplers	Reach Surgical, Inc.	2012	—
+3	K131511	Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable…	Changzhou Sinolinks Medical Innovation Co., Ltd.	2013	—
+3	K141367	LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and…	Touchstone International Medical Science Co., Ltd.	2014	—
+4	K173443	AEON Endoscopic Stapler	Lexington Medical, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	2	0
2012	1	0
2013	2	0
2014	3	0
2016	2	0
2017	1	0
2018	2	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2023	2	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K822345, 1982–2025Source: 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.

Planning a device in GDW? 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 15.1 · 14 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?

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

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K090821	Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…	Frankenman International Limited	2009	21
K101378	Frankenman Surgical Staplers	Suzhou Frankenman Medical Equipment Co., Ltd.	2010	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K090821 (Frankenman International Limited, 2009) has gone furthest, with 21 descendants of its own.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDW

3in 2025

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

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

Recalls per year · GDW

3in 2025

2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007high 16,600 (2019) · low 2,380 (2008)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	—

https://510kreport.com/device/K822345 · printed Nov 4, 2026

Cite this page

510(k) Report. “K822345: Disposable Linear Stapler (LSF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K822345

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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