510(k) · Cleared
Recalled · Class I · 2019Modified Endopath Ils
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 May 27, 1994 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 43 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- May 27, 1994
- Review
- 86 days
- Class
- Class II
- Product code
- OCW
- Recalls
- 4 (4 Class I)
- Predicates
- 0
42 later devices descend from it, 1 citing it directly. 5 of the 43 devices in this family, counting this one, have a Class I recall.
- This deviceK940967 Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994
- Descendant · cites it directly · 41 of its ownK983536 Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Recalled (Class I)
- Descendant · 2 generations on · 30 of its ownK991030 Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · Recalled (Class I)
- Descendant · 3 generations on · 22 of its ownK030925 Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model…Ethicon Endo-Surgery, Inc. · 2003 · Recalled (Class I)
- Descendant · 3 generations on · 21 of its ownK090821 Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21…Frankenman International Limited · 2009
- Descendant · 4 generations on · 17 of its ownK120179 Reach Surgical StaplersReach Surgical, Inc. · 2012
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K983536 Proximate Curved and Straight Intraluminal…cites it directly · 1998
- K991030 Proximate HCS Hemorrhoidal Circular Stapler and…2 generations on · 1999
- K030411 Proximate PPH Hemorrhoidal Circular Stapler and…3 generations on · 2003
- K030925 Proximate HCS Hemorrhoidal Circular Stapler and…3 generations on · 2003
Most influential descendants
Showing 5 of 42 · See all- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · cites it directly41descendants
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 2 generations on30descendants
- K030925Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Ethicon Endo-Surgery, Inc. · 2003 · 3 generations on22descendants
- K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited · 2009 · 3 generations on21descendants
- K120179Reach Surgical StaplersReach Surgical, Inc. · 2012 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940967 | Modified Endopath Ils | Ethicon Endo-Surgery, Inc. | 1994 | — |
| +1 | K983536 | Proximate Curved and Straight Intraluminal Staplers | Ethicon Endo-Surgery, Inc. | 1998 | Class I |
| +2 | K991030 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories | Ethicon Endo-Surgery, Inc. | 1999 | Class I |
| +3 | K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01 | Ethicon Endo-Surgery, Inc. | 2003 | Class I |
| +3 | K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS… | Frankenman International Limited | 2009 | — |
| +4 | K120179 | Reach Surgical Staplers | Reach Surgical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 1 |
| 1999 | 1 | 1 |
| 2003 | 2 | 2 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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.
5 devices in this family have 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 12.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (42)
See all 421 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983536 | Proximate Curved and Straight Intraluminal Staplers Class I | 1998 | 41 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2019 | Class I | Z-1272-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1274-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1273-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Apr 11, 2019 | Class I | Z-1271-2019 | Under Investigation by firm | The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
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.
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 112 Class I recalls
- K991030Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesEthicon Endo-Surgery, Inc. · 1999 · 2 generations on · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K030411Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03Ethicon Endo-Surgery, Inc. · 2003 · 3 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K030925Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01Ethicon Endo-Surgery, Inc. · 2003 · 3 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K983536 (Ethicon Endo-Surgery, Inc., 1998) has gone furthest, with 41 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 | — |
https://510kreport.com/device/K940967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940967: Modified Endopath Ils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940967
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026