510(k) · Cleared
ClearedLigaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · FZP Clip, Implantable
Cleared on Sep 10, 2015 as substantially equivalent to K864102 (ETHICON, Inc., 1986) after a 164-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Sep 10, 2015
- Review
- 164 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864102 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK864102 Ligaclip 20/20* Multiple Clip ApplierETHICON, Inc. · 1986 · Recalled
- This deviceK150840 Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip ApplierEthicon Endo-Surgery, LLC · 2015
- Descendant · cites it directly · 0 of its ownK232313 LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420)…Ethicon Endo Surgery, LLC · 2023
- Descendant · cites it directly · 0 of its ownK181488 LIGACLIP 12mm L Endoscopic Rotating Multiple Clip ApplierEthicon Endo-Surgery, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864102 | Ligaclip 20/20* Multiple Clip Applier | ETHICON, Inc. | 1986 | 4 |
| 0 (this device) | K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | Ethicon Endo-Surgery, LLC | 2015 | — |
| +1 | K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP… | Ethicon Endo Surgery, LLC | 2023 | — |
| +1 | K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | Ethicon Endo-Surgery, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 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.
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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K864102 | Ligaclip 20/20* Multiple Clip ApplierSummary page 4…dicate Device Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier submitted as Ligaclip® 20/20 Multiple Clip Applier, K864102 Reference Device Ligamax™ 5, K110699 Device Description The Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip A… | 1986 |
| † | K110699 | Ligamax 5 | 2011 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Ligaclip® Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.
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/K150840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150840: Ligaclip 10mm M/L Endoscopic Rotating Multiple 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/K150840
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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