510(k) Report

510(k) · Cleared

Cleared

Disposable Linear Cutter

K843034510(k) TraditionalCleared Sep 17, 198447-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 17, 1984 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 133 devices in its family, counting itself, has a Class I recall. 132 later devices descend from it.

Decided
Sep 17, 1984
Review
47 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
0

132 later devices descend from it, 4 citing it directly. 1 of the 133 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2002: 1 descendant cleared2004: 6 descendants cleared2003: 2 descendants cleared2012: 5 descendants cleared2016: 9 descendants cleared2014: 10 descendants cleared, 1 with a Class I recall12007: 10 descendants cleared2009: 4 descendants cleared2015: 6 descendants cleared2017: 11 descendants cleared2011: 5 descendants cleared2025: 3 descendants cleared2005: 4 descendants cleared2023: 7 descendants cleared2019: 4 descendants cleared2020: 6 descendants cleared2006: 3 descendants cleared2026: 5 descendants cleared2021: 5 descendants cleared2010: 4 descendants cleared2013: 6 descendants cleared2022: 5 descendants cleared2008: 2 descendants cleared2018: 7 descendants cleared2024: 1 descendant cleared19801990200020102020
  1. This deviceK843034 Disposable Linear CutterETHICON, Inc. · 1984
  2. Descendant · cites it directly · 88 of its ownK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
  3. Descendant · cites it directly · 87 of its ownK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
  4. Descendant · cites it directly · 62 of its ownK040038 Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved…Ethicon Endo-Surgery, Inc. · 2004
  5. Descendant · 2 generations on · 61 of its ownK062869 Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G…Ethicon Endo-Surgery, LLC · 2007
  6. Descendant · 3 generations on · 60 of its ownK091322 Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G…Ethicon Endo-Surgery, Inc. · 2009

Showing 5 of 132 descendants. See all descendants

Descendants cleared per year

1998: 12002: 12003: 22004: 62005: 42006: 32007: 102008: 22009: 42010: 42011: 52012: 52013: 62014: 102015: 62016: 92017: 112018: 72019: 42020: 62021: 52022: 52023: 72024: 12025: 32026: 5
1998high 11 (2017) · 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 132 · 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
  • K040038Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models CR40B, CR40GEthicon Endo-Surgery, Inc. · 2004 · cites it directly62descendants
  • K062869Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GEthicon Endo-Surgery, LLC · 2007 · 2 generations on61descendants
  • K091322Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GEthicon Endo-Surgery, Inc. · 2009 · 3 generations on60descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K843034Disposable Linear CutterETHICON, Inc.1984—
+1K980023Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc.1998—
+1K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc.200217
+1K040038Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models…Ethicon Endo-Surgery, Inc.2004—
+2K062869Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GEthicon Endo-Surgery, LLC2007—
+3K091322Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GEthicon Endo-Surgery, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
200320
200460
200540
200630
2007100
200820
200940
201040
201150
201250
201360
2014101
201560
201690
2017110
201870
201940
202060
202150
202250
202370
202410
202530
202650
FIG. 1 — Lineage of K843034, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GDW device

  1. #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (132)

See all 132

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

NumberDeviceApplicantDecidedDescendants
K980023Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc.199888
K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc.200287
K040038Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models CR40B, CR40GEthicon Endo-Surgery, Inc.200462
K032973Reprocessed Disposable Cutters, Staplers and AppliersVanguard Medical Concepts, Inc.20030

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 GDW devices

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

FDA decisions per year · GDW

3in 2025

2007: 82008: 72009: 132010: 102011: 112012: 92013: 132014: 152015: 82016: 112017: 132018: 72019: 122020: 102021: 92022: 72023: 42024: 22025: 32026 (partial year): 3
2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007: 56 days median2008: 57 days median2009: 27 days median2010: 39 days median2011: 49 days median2012: 45 days median2013: 49 days median2014: 63 days median2015: 111 days median2016: 96 days median2017: 103 days median2018: 90 days median2019: 205 days median2020: 88 days median2021: 233 days median2022: 89 days median2023: 267 days median2025: 111 days median2026 (partial year): 141 days median
2007high 267 (2023) · low 27 (2009)2026

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

Recalls per year · GDW

3in 2025

2007: 92009: 222010: 22011: 92012: 11, 1 Class I2013: 12015: 62016: 22017: 32018: 32019: 4, 4 Class I2020: 112023: 12025: 3
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

2007: 2,4012008: 2,3802009: 4,0142010: 3,7682011: 3,8262012: 3,7172013: 3,7772014: 4,7842015: 4,8992016: 5,1062017: 11,6432018: 14,9142019: 16,6002020: 12,3322021: 13,0152022: 13,6052023: 14,6232024: 13,2802025: 11,905
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200785692,401
200875702,380
20091327224,014
2010103923,768
2011114993,826
201294511 (1)3,717
2013134913,777
2014156304,784
2015811164,899
2016119625,106
201713103311,643
2018790314,914
2019122054 (4)16,600
202010881112,332
20219233013,015
2022789013,605
20234267114,623
20242—013,280
20253111311,905
202631410—

More from ETHICON, Inc.

654 FDA decisions under this applicant name. See the company

  • P240035/S004ETHIZIA™ Hemostatic PatchETHICON, Inc. · 2026
  • N12159/S129SURGICELTM POWDER Absorbable Hemostatic PowderETHICON, Inc. · 2026
  • P240035/S002ETHIZIA Hemostatic PatchETHICON, Inc. · 2026
  • P880047/S070GYNECARE INTERCEED™ Absorbable Adhesion BarrierETHICON, Inc. · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026

Recent decisions in GDW

The GDW category page

  • K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic…Ezisurg Medical Co., Ltd. · 2026
  • K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler…Ethicon Endo-Surgery, LLC · 2026
  • K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads…Covidien (Part of Medtronic) · 2026
  • K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000…Ethicon Endo-Surgery, LLC · 2025
  • K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025

https://510kreport.com/device/K843034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K843034: Disposable Linear Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843034

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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