510(k) · Cleared
Recalled · Class II · 2013Ligaclip Titanium Ligating Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · FZP Clip, Implantable
Cleared on Mar 8, 1983 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 8, 1983
- Review
- 20 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 3
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK830503 Ligaclip Titanium Ligating ClipETHICON, Inc. · 1983
- 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 · 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
- Descendant · cites it directly · 1 of its ownK100090 Implantable ClipGenicon · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · 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
- K140932Amsel Occluder DeviceAmsel Medical Corporation · 2015 · 2 generations on2descendants
- K110699Ligamax 5Ethicon Endo-Sugery, LLC · 2011 · 2 generations on1descendant
- K100090Implantable ClipGenicon · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830503 | Ligaclip Titanium Ligating Clip | ETHICON, Inc. | 1983 | — |
| +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 | — |
| +2 | K140932 | Amsel Occluder Device | Amsel Medical Corporation | 2015 | — |
| +2 | K110699 | Ligamax 5 | Ethicon Endo-Sugery, LLC | 2011 | 1 |
| +1 | K100090 | Implantable Clip | Genicon | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 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? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
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/K830503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K830503: Ligaclip Titanium Ligating Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830503
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