510(k) Report

510(k) · Cleared

Cleared

Mar-Med Liver Strap

K924223510(k) TraditionalCleared Mar 18, 1993209-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

Mar-Med Co. · GDJ Clamp, Surgical, General & Plastic Surgery

Cleared on Mar 18, 1993 after a 209-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 18, 1993
Review
209 days
Class
Class I
Product code
GDJ
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2008: 1 descendant cleared1990200020102020
  1. This deviceK924223 Mar-Med Liver StrapMar-Med Co. · 1993
  2. Descendant · cites it directly · 1 of its ownK061796 Hepatostat Set, Model 760XVygon Corp. · 2006
  3. Descendant · 2 generations on · 0 of its ownK073493 Hepatostat SetVygon Corp. · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K061796Hepatostat Set, Model 760XVygon Corp. · 2006 · cites it directly1descendant
  • K073493Hepatostat SetVygon Corp. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924223Mar-Med Liver StrapMar-Med Co.1993—
+1K061796Hepatostat Set, Model 760XVygon Corp.2006—
+2K073493Hepatostat SetVygon Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
FIG. 1 — Lineage of K924223, 1993–2008Source: 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061796Hepatostat Set, Model 760XVygon Corp.20061

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, K061796 (Vygon Corp., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GDJ devices

GDJ Clamp, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDJ

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDJ

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

Recalls per year · GDJ

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

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

Adverse event reports per year · GDJ

21in 2025

2007: 32008: 32009: 22010: 132011: 42012: 62013: 42014: 72015: 52016: 82017: 152018: 172019: 142020: 72021: 252022: 202023: 292024: 672025: 21
2007high 67 (2024) · low 2 (2009)2025

MAUDE reports naming product code GDJ, 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—03
20080—03
20090—02
20100—013
20110—04
20120—06
20130—04
20140—07
20150—05
20161—08
20170—015
20180—017
20190—014
20200—07
20210—025
20220—020
20230—029
20240—167
20250—021
20260—0—

Recent decisions in GDJ

The GDJ category page

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  • K930315Thoracic Clamps: Sarot, Kantowitz and LawrenceThomasville Medical Assoc. · 1994
  • K922659General Surgery Clamp and Needle HolderMiltex Instrument Co. · 1992
  • K914913Grice Foot Pedal Control/Reddick Irri/Aspir SystIdeal Medical, Inc. · 1991
  • K900956GS-7100 Cholangiogram Clamp, 5MMSolos Endoscopy, Inc. · 1990

https://510kreport.com/device/K924223 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924223: Mar-Med Liver Strap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924223

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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