510(k) · Cleared
ClearedLigaclip 5 M/L MM Endoscopic Multiple Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo Surgery, Inc. · FZP Clip, Implantable
Cleared on Mar 14, 2005 as substantially equivalent to K864102 (ETHICON, Inc., 1986) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 1983. 3 later devices descend from it.
- Decided
- Mar 14, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K830503 (1983). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK830503 Ligaclip Titanium Ligating ClipETHICON, Inc. · 1983 · Recalled
- This deviceK050344 Ligaclip 5 M/L MM Endoscopic Multiple Clip ApplierEthicon Endo Surgery, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK110699 Ligamax 5Ethicon Endo-Sugery, LLC · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK180650 Amsel Endo OccluderAmsel Medical Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK150936 SureClipConmed Corporation · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830503 | Ligaclip Titanium Ligating Clip | ETHICON, Inc. | 1983 | 3 |
| 0 (this device) | K050344 | Ligaclip 5 M/L MM Endoscopic Multiple Clip Applier | Ethicon Endo Surgery, Inc. | 2005 | — |
| +1 | K110699 | Ligamax 5 | Ethicon Endo-Sugery, LLC | 2011 | 1 |
| +1 | K180650 | Amsel Endo Occluder | Amsel Medical Corporation | 2018 | — |
| +2 | K150936 | SureClip | Conmed Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (2)
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 1…ip Applier Classification Name: Implantable Clip Predicate Devices: Trade Name: LIGACLIP® ERCA Endoscopic Rotating Multiple Clip Applier Cleared under 510(k) numbers K0864102 on November 5, 1986. The Titanium Clips used with the applier were cleared March 9, 1983 under K830503. Device Description The… | 1986 |
| * | K830503 | Ligaclip Titanium Ligating ClipSummary page 1…copic Rotating Multiple Clip Applier Cleared under 510(k) numbers K0864102 on November 5, 1986. The Titanium Clips used with the applier were cleared March 9, 1983 under K830503. Device Description The LIGACLIP® 5 M/L Endoscopic Multiple Clip Applier is a sterile, single patient… | 1983 |
What descends from it? (3)
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.
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® 5 M/L 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
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/K050344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050344: Ligaclip 5 M/L MM Endoscopic 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/K050344
Report an extraction error
Are you the manufacturer?
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