510(k) Report

510(k) · Cleared

Cleared

Proximate Articulating Linear Stapler

K932434510(k) TraditionalCleared Feb 7, 1994263-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. · OCW Endoscopic Tissue Approximation Device

Cleared on Feb 7, 1994 after a 263-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 131 devices in its family, counting itself, has a Class I recall. 130 later devices descend from it.

Decided
Feb 7, 1994
Review
263 days
Class
Class II
Product code
OCW
Recalls
None
Predicates
0

130 later devices descend from it, 2 citing it directly. 1 of the 131 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 1 descendant cleared2004: 6 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 cleared2003: 1 descendant 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 cleared1990200020102020
  1. This deviceK932434 Proximate Articulating Linear StaplerEthicon Endo-Surgery, Inc. · 1994
  2. Descendant · cites it directly · 87 of its ownK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
  3. Descendant · cites it directly · 62 of its ownK040038 Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved…Ethicon Endo-Surgery, Inc. · 2004
  4. Descendant · 2 generations on · 61 of its ownK062869 Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G…Ethicon Endo-Surgery, LLC · 2007
  5. Descendant · 3 generations on · 60 of its ownK091322 Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G…Ethicon Endo-Surgery, Inc. · 2009
  6. Descendant · 2 generations on · 46 of its ownK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003

Showing 5 of 130 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 62005: 42006: 32007: 102008: 22009: 42010: 42011: 52012: 52013: 62014: 102015: 62016: 92017: 112018: 72019: 42020: 62021: 52022: 52023: 72024: 12025: 32026: 5
2002high 11 (2017) · low 1 (2002)2026

Class I recalls in this family

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

Most influential descendants

Showing 5 of 130 · See all
  • 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
  • K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc. · 2003 · 2 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932434Proximate Articulating Linear StaplerEthicon Endo-Surgery, Inc.1994—
+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—
+2K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital…Power Medical Interventions, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
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 K932434, 1994–2026Source: 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), 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 OCW device

  1. #1 K252400 Endomina EZFuse systemscore 12.0 · 5 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? (130)

See all 130

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

NumberDeviceApplicantDecidedDescendants
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

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, K020779 (Ethicon Endo-Surgery, Inc., 2002) has gone furthest, with 87 descendants of its own.

How does its category compare?

All OCW devices

OCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCW

1in 2025

2007: 52008: 42009: 32010: 42011: 12012: 12013: 22016: 22017: 22018: 22019: 12020: 12021: 32023: 32025: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCW

133in 2023

2007: 58 days median2008: 70 days median2009: 30 days median2010: 91 days median2021: 221 days median2023: 133 days median
2007high 221 (2021) · low 30 (2009)2026

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

Recalls per year · OCW

3so far in 2026, the most since 2007

2023: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OCW

326in 2025

2007: 92008: 472009: 302010: 102011: 162012: 282013: 22014: 282015: 592016: 742017: 4202018: 4132019: 2912020: 1832021: 1982022: 2352023: 2272024: 2112025: 326
2007high 420 (2017) · low 2 (2013)2025

MAUDE reports naming product code OCW, 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
200755809
2008470047
2009330030
2010491010
20111—016
20121—028
20132—02
20140—028
20150—059
20162—074
20172—0420
20182—0413
20191—0291
20201—0183
202132210198
20220—0235
202331331227
20240—0211
20251—0326
20262—3—

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 OCW

The OCW category page

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  • K231240MaxTack™ Motorized Fixation DeviceCovidien · 2023
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https://510kreport.com/device/K932434 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932434: Proximate Articulating Linear Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932434

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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