510(k) Report

510(k) · Cleared

Cleared

Endopath Ils Endoscopic Circular Stapler

K920752510(k) TraditionalCleared Aug 6, 1992169-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 Aug 6, 1992 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.

Decided
Aug 6, 1992
Review
169 days
Class
Class II
Product code
GDW
Recalls
None
Predicates
0

32 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2010: 3 descendants cleared2009: 1 descendant cleared2013: 3 descendants cleared2005: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2017: 2 descendants cleared2019: 3 descendants cleared2014: 3 descendants cleared2022: 1 descendant cleared2016: 2 descendants cleared2018: 2 descendants cleared2021: 1 descendant cleared2023: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK920752 Endopath Ils Endoscopic Circular StaplerETHICON, Inc. · 1992
  2. Descendant · cites it directly · 21 of its ownK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
  3. Descendant · 2 generations on · 17 of its ownK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
  4. Descendant · 3 generations on · 14 of its ownK131511 Disposable Circular Stapler, Disposable Curved Cutter Stapler…Changzhou Sinolinks Medical Innovation Co., Ltd. · 2013
  5. 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
  6. Descendant · 4 generations on · 5 of its ownK173443 AEON Endoscopic StaplerLexington Medical, Inc. · 2018

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12006: 12009: 12010: 32011: 12012: 12013: 32014: 32016: 22017: 22018: 22019: 32020: 12021: 12022: 12023: 22024: 12025: 1
2003high 3 (2010) · low 0 (2007)2026

Most influential descendants

Showing 5 of 32 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920752Endopath Ils Endoscopic Circular StaplerETHICON, Inc.1992—
+1K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS…Frankenman International Limited2009—
+2K120179Reach Surgical StaplersReach Surgical, Inc.2012—
+3K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable…Changzhou Sinolinks Medical Innovation Co., Ltd.2013—
+3K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and…Touchstone International Medical Science Co., Ltd.2014—
+4K173443AEON Endoscopic StaplerLexington Medical, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200610
200910
201030
201110
201210
201330
201430
201620
201720
201820
201930
202010
202110
202210
202320
202410
202510
FIG. 1 — Lineage of K920752, 1992–2025Source: 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.

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 15.1 · 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? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited200921
K100723Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5Changzhou Kangdi Medical Stapler Co., Ltd.20103
K050356Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20052
K101378Frankenman Surgical StaplersSuzhou Frankenman Medical Equipment Co., Ltd.20101
K032701Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33)Power Medical Interventions, Inc.20031
K131303Disposable Circular StaplerChangzhou City Zhiye Medical Devices Institute Co.20130

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

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/K920752 · printed Nov 3, 2026

Cite this page

510(k) Report. “K920752: Endopath Ils Endoscopic Circular Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K920752

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