510(k) Report

510(k) · Cleared

Cleared

Reprocessed Multiple Clip Appliers

K033579510(k) TraditionalCleared Jul 11, 2005606-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

Clearmedical, Inc. · NMJ Clip, Implantable, Reprocessed

Cleared on Jul 11, 2005 as substantially equivalent to K771412 (ETHICON, Inc., 1977) after a 606-day review. Its family tree reaches back 1 generation to 1977.

Decided
Jul 11, 2005
Review
606 days
Class
Class II
Product code
NMJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K771412 (1977). No later device cites it as a predicate yet.

K771412 · Ligaclip Multiple Clip Applier · ETHICON, Inc. · 19771975198019851990199520002005
K771412 · Ligaclip Multiple Clip Applier · ETHICON, Inc. · 19770
  1. Root · 1 generation backK771412 Ligaclip Multiple Clip ApplierETHICON, Inc. · 1977
  2. This deviceK033579 Reprocessed Multiple Clip AppliersClearmedical, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K771412Ligaclip Multiple Clip ApplierETHICON, Inc.1977—
0 (this device)K033579Reprocessed Multiple Clip AppliersClearmedical, Inc.2005—
FIG. 1 — Lineage of K033579, 1977–2005Source: 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), 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.

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  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K771412Ligaclip Multiple Clip Applier
Summary page 1
…pliers Classification name: Manual surgical instrument for general use (21 CFR 878.4800) Product code: GDO - Applier, Surgical, Clip Predicate device: K771412 - Ethicon Ligaclip MCA clip appliers Device description: The reprocessed multiple clip applier is an automatic ligating clip…
ETHICON, Inc.1977—

Also cleared against K771412: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K771412.

How does its category compare?

All NMJ devices

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

FDA decisions per year · NMJ

FDA has decided no NMJ device since 2007.

Median 510(k) review, days · NMJ

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

Recalls per year · NMJ

No recall names NMJ since 2007.

Adverse event reports per year · NMJ

11in 2021

2011: 22012: 902013: 442014: 642015: 112016: 122017: 42018: 72019: 112020: 12021: 11
2007high 90 (2012) · low 0 (2007)2025

MAUDE reports naming product code NMJ, 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—00
20080—00
20090—00
20100—00
20110—02
20120—090
20130—044
20140—064
20150—011
20160—012
20170—04
20180—07
20190—011
20200—01
20210—011
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Ethicon Ligaclip Multiple Clip Appliers are instruments used

for ligation of tubular structures and vessels.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K771412

1 other device cites the same predicate.

  • K994160Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000

More from Clearmedical, Inc.

14 FDA decisions under this applicant name. See the company

  • K033578Reprocessed Reloadable Cutters, Staplers, and AppliersClearmedical, Inc. · 2005
  • K033591Reprocessed TrocarsClearmedical, Inc. · 2005
  • K033592Reprocessed Surgical Scissors and GraspersClearmedical, Inc. · 2004
  • K033593Reprocessed Single Use Devices Biopsy ForcepsClearmedical, Inc. · 2003
  • K031416Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure CuffClearmedical, Inc. · 2003

https://510kreport.com/device/K033579 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033579: Reprocessed Multiple Clip Appliers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033579

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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