510(k) · Cleared
ClearedEndopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · GDW Staple, Implantable
Cleared on May 18, 2015 as substantially equivalent to K070887 (Ethicon Endo-Surgery, LLC, 2007) and 4 other predicates after a 131-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- May 18, 2015
- Review
- 131 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K821994 (1982). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK821994 Disposable Linear Stapler-(LSR)ETHICON, Inc. · 1982
- 2 generations backK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
- 1 generation backK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
- This deviceK150026 Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath…Ethicon Endo-Surgery, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K821994 | Disposable Linear Stapler-(LSR) | ETHICON, Inc. | 1982 | — |
| −2 | K980023 | Endopath and Proximate Linear Cutters | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −1 | K020779 | Proximate and Endopath Linear Cutters and Staplers | Ethicon Endo-Surgery, Inc. | 2002 | 17 |
| 0 (this device) | K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45… | Ethicon Endo-Surgery, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
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 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
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and…Summary page 4…GDW Marketed Predicate Device Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and Endopath® ETS- Flex45 No-Knife Articulating Linear Stapler (K070887, K061156, K020079, K002398, K961390) Device Description The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a ster… | 2007 |
| * | K061156 | Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and…Summary page 4…Marketed Predicate Device Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and Endopath® ETS- Flex45 No-Knife Articulating Linear Stapler (K070887, K061156, K020079, K002398, K961390) Device Description The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, sing… | 2006 |
| * | K020779 | Proximate and Endopath Linear Cutters and Staplers Our reading of the summary gave K020079, FDA’s number for Bladeworks Microkeratome Blade, Model 7061 (Blade Works, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and…”. | 2002 |
| * | K002398 | Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets…Summary page 4…Device Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and Endopath® ETS- Flex45 No-Knife Articulating Linear Stapler (K070887, K061156, K020079, K002398, K961390) Device Description The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, single patient use ins… | 2000 |
| * | K961390 | Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic CutterSummary page 4…Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and Endopath® ETS- Flex45 No-Knife Articulating Linear Stapler (K070887, K061156, K020079, K002398, K961390) Device Description The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, single patient use instrument t… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- 4 of the 19 ancestors have a recall of any class.
- 10 other devices also cite its predicate K070887.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 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 | — |
What is it indicated for?
The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and
reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in
multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can
be used with staple line buttressing material. The instrument may also be used for transection and resection of liver
parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150026 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150026: Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150026
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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