510(k) · Cleared
ClearedEndopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic Linear Stapler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Jun 27, 1997 after a 120-day review. The FDA summary names no predicate by number. 1 of the 95 devices in its family, counting itself, has a Class I recall. 94 later devices descend from it.
- Decided
- Jun 27, 1997
- Review
- 120 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 3 citing it directly. 1 of the 95 devices in this family, counting this one, has a Class I recall.
- This deviceK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- Descendant · cites it directly · 92 of its ownK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- Descendant · cites it directly · 88 of its ownK980023 Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc. · 1998
- Descendant · cites it directly · 87 of its ownK020779 Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 47 of its ownK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
- 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 94 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141952 Echelon Flex Powered Vascular Stapler with…2 generations on · 2014
Most influential descendants
Showing 5 of 94 · See all- K980815Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998 · cites it directly92descendants
- 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
- K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and…Power Medical Interventions, Inc. · 2002 · 2 generations on47descendants
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| +1 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| +1 | 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 |
| +2 | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | 1 |
| +2 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 1 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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.
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 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (94)
See all 943 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K980815 (Ethicon Endo-Surgery, Inc., 1998) has gone furthest, with 92 descendants of its own.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970720: Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic 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/K970720
Report an extraction error
Are you the manufacturer?
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