510(k) · Cleared
Recalled · Class II · 2013Ligaclip 20/20* Multiple Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · FZP Clip, Implantable
Cleared on Nov 5, 1986 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 5, 1986
- Review
- 15 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 4
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK864102 Ligaclip 20/20* Multiple Clip ApplierETHICON, Inc. · 1986
- Descendant · cites it directly · 3 of its ownK050344 Ligaclip 5 M/L MM Endoscopic Multiple Clip ApplierEthicon Endo Surgery, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK032238 Twister Superelastic Ligating Clip and ApplierNeurosel (Medical) Limited · 2003
- Descendant · cites it directly · 2 of its ownK150840 Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip ApplierEthicon Endo-Surgery, LLC · 2015
- Descendant · 2 generations on · 2 of its ownK140932 Amsel Occluder DeviceAmsel Medical Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK110699 Ligamax 5Ethicon Endo-Sugery, LLC · 2011 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K050344Ligaclip 5 M/L MM Endoscopic Multiple Clip ApplierEthicon Endo Surgery, Inc. · 2005 · cites it directly3descendants
- K032238Twister Superelastic Ligating Clip and ApplierNeurosel (Medical) Limited · 2003 · cites it directly3descendants
- K150840Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip ApplierEthicon Endo-Surgery, LLC · 2015 · cites it directly2descendants
- K140932Amsel Occluder DeviceAmsel Medical Corporation · 2015 · 2 generations on2descendants
- K110699Ligamax 5Ethicon Endo-Sugery, LLC · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864102 | Ligaclip 20/20* Multiple Clip Applier | ETHICON, Inc. | 1986 | — |
| +1 | K050344 | Ligaclip 5 M/L MM Endoscopic Multiple Clip Applier | Ethicon Endo Surgery, Inc. | 2005 | — |
| +1 | K032238 | Twister Superelastic Ligating Clip and Applier | Neurosel (Medical) Limited | 2003 | — |
| +1 | K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | Ethicon Endo-Surgery, LLC | 2015 | — |
| +2 | K140932 | Amsel Occluder Device | Amsel Medical Corporation | 2015 | — |
| +2 | K110699 | Ligamax 5 | Ethicon Endo-Sugery, LLC | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 3 | 0 |
| 2018 | 2 | 0 |
| 2023 | 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.
Planning a device in FZP? 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 FZP device
- #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 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? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050344 | Ligaclip 5 M/L MM Endoscopic Multiple Clip Applier | 2005 | 3 |
| K032238 | Twister Superelastic Ligating Clip and Applier | 2003 | 3 |
| K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | 2015 | 2 |
| K260677 | Vessel Closure Device (VCD177213P) | 2026 | 0 |
| K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | 2018 | 0 |
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… |
| Jun 7, 2004 | Not classified | Z-1055-04 | Other | This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050344 (Ethicon Endo Surgery, Inc., 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, 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 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K864102 · printed Nov 4, 2026
Cite this page
510(k) Report. “K864102: Ligaclip 20/20* Multiple Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864102
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026