510(k) Report

510(k) · Cleared

Cleared

Ligaclip Multiple Clip Applier

K771412510(k) TraditionalCleared Nov 28, 1977119-day reviewClass I21 CFR 878.4800

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

ETHICON, Inc. · GDO Applier, Surgical, Clip

Cleared on Nov 28, 1977 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.

Decided
Nov 28, 1977
Review
119 days
Class
Class I
Product code
GDO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2000: 1 descendant cleared2005: 4 descendants cleared2008: 1 descendant cleared2004: 5 descendants cleared2003: 2 descendants cleared2002: 3 descendants cleared2001: 2 descendants cleared2006: 4 descendants cleared2010: 3 descendants cleared2022: 2 descendants cleared2007: 4 descendants cleared2009: 1 descendant cleared2015: 3 descendants cleared2017: 3 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2016: 3 descendants cleared2025: 1 descendant cleared2011: 1 descendant cleared2020: 1 descendant cleared2026: 3 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared19801990200020102020
  1. This deviceK771412 Ligaclip Multiple Clip ApplierETHICON, Inc. · 1977
  2. Descendant · cites it directly · 55 of its ownK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  3. Descendant · 2 generations on · 52 of its ownK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  4. Descendant · 3 generations on · 44 of its ownK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  5. Descendant · 4 generations on · 43 of its ownK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  6. Descendant · 2 generations on · 42 of its ownK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2000: 12001: 22002: 32003: 22004: 52005: 42006: 42007: 42008: 12009: 12010: 32011: 12012: 12013: 12014: 12015: 32016: 32017: 32018: 22019: 12020: 12021: 12022: 22023: 22024: 12025: 12026: 3
2000high 5 (2004) · low 1 (2000)2026

Most influential descendants

Showing 5 of 57 · See all
  • K994160Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000 · cites it directly55descendants
  • K012317Coalescent Surgical U-ClipCoalescent Surgical · 2001 · 2 generations on52descendants
  • K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002 · 3 generations on44descendants
  • K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002 · 4 generations on43descendants
  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002 · 2 generations on42descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K771412Ligaclip Multiple Clip ApplierETHICON, Inc.1977—
+1K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
+2K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
+3K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
+4K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
+2K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200230
200320
200450
200540
200640
200740
200810
200910
201030
201110
201210
201310
201410
201530
201630
201730
201820
201910
202010
202110
202220
202320
202410
202510
202630
FIG. 1 — Lineage of K771412, 1977–2026Source: 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 GDO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K994160Coalescent Surgical Sutured-ClipCoalescent Surgical200055
K033579Reprocessed Multiple Clip AppliersClearmedical, Inc.20050

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, K994160 (Coalescent Surgical, 2000) has gone furthest, with 55 descendants of its own.

How does its category compare?

All GDO devices

GDO Applier, Surgical, Clip: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDO

FDA has decided no GDO device since 2007.

Median 510(k) review, days · GDO

Too few GDO 510(k)s in any year since 2007 to give a median.

Recalls per year · GDO

No recall names GDO since 2007.

Adverse event reports per year · GDO

543in 2025

2007: 5232008: 4252009: 5472010: 4472011: 1702012: 1792013: 2322014: 3072015: 1842016: 4402017: 3152018: 3682019: 2932020: 2212021: 3042022: 3612023: 3652024: 2872025: 543
2007high 547 (2009) · low 170 (2011)2025

MAUDE reports naming product code GDO, 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
20070—0523
20080—0425
20090—0547
20100—0447
20110—0170
20120—0179
20130—0232
20140—0307
20150—0184
20160—0440
20170—0315
20180—0368
20190—0293
20200—0221
20210—0304
20220—0361
20230—0365
20240—0287
20250—0543
20260—0—
Cite this page

510(k) Report. “K771412: Ligaclip 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/K771412

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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