510(k) Report

510(k) · Cleared

Cleared

Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models CR40B, CR40G

K040038510(k) TraditionalCleared Feb 4, 200427-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 Endo-Surgery, Inc. · GDW Staple, Implantable

Cleared on Feb 4, 2004 as substantially equivalent to K932434 (Ethicon Endo-Surgery, Inc., 1994) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1984. 62 later devices descend from it.

Decided
Feb 4, 2004
Review
27 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K843034 (1984). 2 ancestors in all. 62 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2007: 1 descendant cleared2020: 6 descendants cleared2017: 7 descendants cleared2009: 1 descendant cleared2010: 2 descendants cleared2013: 5 descendants cleared2015: 3 descendants cleared2021: 3 descendants cleared2011: 1 descendant cleared2012: 4 descendants cleared2016: 6 descendants cleared2014: 7 descendants cleared2019: 1 descendant cleared2026: 1 descendant cleared2018: 4 descendants cleared2023: 4 descendants cleared2022: 4 descendants cleared2025: 1 descendant cleared2024: 1 descendant clearedK843034 · Disposable Linear Cutter · ETHICON, Inc. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 7 descendants5 generations forward: 26 descendants6 generations forward: 14 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant9 generations forward: 2 descendants K843034 · Disposable Linear Cutter · ETHICON, Inc. · 19840+5
  1. Root · 1 generation backK843034 Disposable Linear CutterETHICON, Inc. · 1984
  2. This deviceK040038 Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved…Ethicon Endo-Surgery, Inc. · 2004
  3. Descendant · cites it directly · 61 of its ownK062869 Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G…Ethicon Endo-Surgery, LLC · 2007
  4. Descendant · 2 generations on · 60 of its ownK091322 Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G…Ethicon Endo-Surgery, Inc. · 2009
  5. Descendant · 3 generations on · 45 of its ownK102291 Covidien Endo Gia Radial Reload with Tri-Staple TechnologyCovidien · 2010
  6. Descendant · 4 generations on · 44 of its ownK111825 Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
  7. Descendant · 3 generations on · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 22011: 12012: 42013: 52014: 72015: 32016: 62017: 72018: 42019: 12020: 62021: 32022: 42023: 42024: 12025: 12026: 1
2007high 7 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 62 · See all
  • K062869Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GEthicon Endo-Surgery, LLC · 2007 · cites it directly61descendants
  • K091322Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GEthicon Endo-Surgery, Inc. · 2009 · 2 generations on60descendants
  • K102291Covidien Endo Gia Radial Reload with Tri-Staple TechnologyCovidien · 2010 · 3 generations on45descendants
  • K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · 4 generations on44descendants
  • K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K843034Disposable Linear CutterETHICON, Inc.1984—
0 (this device)K040038Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models…Ethicon Endo-Surgery, Inc.2004—
+1K062869Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GEthicon Endo-Surgery, LLC2007—
+2K091322Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GEthicon Endo-Surgery, Inc.2009—
+3K102291Covidien Endo Gia Radial Reload with Tri-Staple TechnologyCovidien2010—
+4K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA…Covidien, Formerly US Surgical A Divison of Tyco H201173
+3K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable…Changzhou Sinolinks Medical Innovation Co., Ltd.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201020
201110
201240
201350
201470
201530
201660
201770
201840
201910
202060
202130
202240
202340
202410
202510
202610
FIG. 1 — Lineage of K040038, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

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. #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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K932434Proximate Articulating Linear Stapler
Summary page 1
…e of Device Trade Name: Curved Cutter Stapler Classification Name: Staple, Implantable Predicate Devices: PROXIMATE ACCESS 55 Articulating Linear Stapler, cleared under K932434 on 02/07/94. PROXIMATE Linear Cutter, cleared under K843034 on 09/17/84. Device Description The Curved Cutter Stapler is a steri…
Ethicon Endo-Surgery, Inc.1994—
*K843034Disposable Linear Cutter
Summary page 1
…Name: Staple, Implantable Predicate Devices: PROXIMATE ACCESS 55 Articulating Linear Stapler, cleared under K932434 on 02/07/94. PROXIMATE Linear Cutter, cleared under K843034 on 09/17/84. Device Description The Curved Cutter Stapler is a sterile, single use device with a curved head that cuts and stapl…
ETHICON, Inc.1984—

Also cleared against K932434: 1 other device →

What descends from it? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K062869Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GEthicon Endo-Surgery, LLC200761
K200420Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green…Ethicon Endo-Surgery, LLC20200

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K062869 (Ethicon Endo-Surgery, LLC, 2007) has gone furthest, with 61 descendants of its own.
  • 1 other device also cites its predicate K932434.

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—

What is it indicated for?

The Curved Cutter Stapler is intended for use in gastrointestinal surgical procedures for transection and resection of tissues.

Indications for use as stated in the FDA summary.

Also cleared against K932434

1 other device cites the same predicate.

  • K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 200217 recalls

More from Ethicon Endo-Surgery, Inc.

111 FDA decisions under this applicant name. See the company

  • K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 20141 Class I recall
  • K111195Valutrus Reusable Circular Stapler and Disposable ReloadsEthicon Endo-Surgery, Inc. · 2011
  • K110385Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011
  • K101520Enseal Tissue Sealing Devices Model: NSEAL514H-535H, NSEAL514RH-535RHEthicon Endo-Surgery, Inc. · 2010
  • K102632Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed StaplerEthicon Endo-Surgery, Inc. · 2010

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/K040038 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040038: Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models CR40B, CR40G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040038

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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