510(k) · Cleared
Recalled · Class II · 2013Ethicon Multiple Ligating Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GDO Applier, Surgical, Clip
Cleared on Sep 11, 1981 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 3 times.
- Decided
- Sep 11, 1981
- Review
- 29 days
- Class
- Class I
- Product code
- GDO
- Recalls
- 3
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 GDO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2013 | Class II | Z-1775-2013 | Under Investigation by firm | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage… |
| Apr 12, 2013 | Class II | Z-1777-2013 | Under Investigation by firm | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage… |
| Apr 12, 2013 | Class II | Z-1776-2013 | Under Investigation by firm | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All GDO devicesGDO Applier, Surgical, Clip: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDO
FDA has decided no GDO device since 2007.
Median 510(k) review, days · GDO
Too few GDO 510(k)s in any year since 2007 to give a median.
Recalls per year · GDO
No recall names GDO since 2007.
Adverse event reports per year · GDO
543in 2025
MAUDE reports naming product code GDO, 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 | 0 | — | 0 | 523 |
| 2008 | 0 | — | 0 | 425 |
| 2009 | 0 | — | 0 | 547 |
| 2010 | 0 | — | 0 | 447 |
| 2011 | 0 | — | 0 | 170 |
| 2012 | 0 | — | 0 | 179 |
| 2013 | 0 | — | 0 | 232 |
| 2014 | 0 | — | 0 | 307 |
| 2015 | 0 | — | 0 | 184 |
| 2016 | 0 | — | 0 | 440 |
| 2017 | 0 | — | 0 | 315 |
| 2018 | 0 | — | 0 | 368 |
| 2019 | 0 | — | 0 | 293 |
| 2020 | 0 | — | 0 | 221 |
| 2021 | 0 | — | 0 | 304 |
| 2022 | 0 | — | 0 | 361 |
| 2023 | 0 | — | 0 | 365 |
| 2024 | 0 | — | 0 | 287 |
| 2025 | 0 | — | 0 | 543 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K812291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K812291: Ethicon Multiple Ligating Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K812291
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026