510(k) Report

510(k) · Cleared

Cleared

Ligaclip Metallic Ligating Clip

K834267510(k) TraditionalCleared Mar 12, 198495-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

ETHICON, Inc. · FZP Clip, Implantable

Cleared on Mar 12, 1984 after a 95-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Mar 12, 1984
Review
95 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
0

11 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared2026: 2 descendants cleared2022: 1 descendant cleared2024: 3 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared19801990200020102020
  1. This deviceK834267 Ligaclip Metallic Ligating ClipETHICON, Inc. · 1984
  2. Descendant · cites it directly · 7 of its ownK200166 Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited. · 2020
  3. Descendant · 2 generations on · 6 of its ownK212127 PicocaremajestyWontech Co., Ltd. · 2022
  4. Descendant · 3 generations on · 2 of its ownK233018 PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023
  5. Descendant · cites it directly · 2 of its ownK140932 Amsel Occluder DeviceAmsel Medical Corporation · 2015
  6. Descendant · 3 generations on · 1 of its ownK233007 Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2015: 12018: 12020: 12022: 12023: 12024: 32025: 12026: 2
2015high 3 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 11 · See all
  • K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited. · 2020 · cites it directly7descendants
  • K212127PicocaremajestyWontech Co., Ltd. · 2022 · 2 generations on6descendants
  • K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd. · 2023 · 3 generations on2descendants
  • K140932Amsel Occluder DeviceAmsel Medical Corporation · 2015 · cites it directly2descendants
  • K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K834267Ligaclip Metallic Ligating ClipETHICON, Inc.1984—
+1K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited.2020—
+2K212127PicocaremajestyWontech Co., Ltd.2022—
+3K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.2023—
+1K140932Amsel Occluder DeviceAmsel Medical Corporation2015—
+3K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201810
202010
202210
202310
202430
202510
202620
FIG. 1 — Lineage of K834267, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited.20207
K140932Amsel Occluder DeviceAmsel Medical Corporation20152

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?

  • Of its descendants, K200166 (M/s. Meril Endo Surgery Private Limited., 2020) has gone furthest, with 7 descendants of its own.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZP

5in 2025

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
2007high 6 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FZP

1,902in 2025

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—
Cite this page

510(k) Report. “K834267: Ligaclip Metallic 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/K834267

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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