510(k) Report

510(k) · Cleared

Recalled · 2010

Wilson Cook Multiple Band Ligator

K944220510(k) TraditionalCleared Jan 24, 1995148-day reviewClass II21 CFR 876.4400Recalls 2

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

Wilson-Cook Medical, Inc. · MND Ligator, Esophageal

Cleared on Jan 24, 1995 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.

Decided
Jan 24, 1995
Review
148 days
Class
Class II
Product code
MND
Recalls
2
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK944220 Wilson Cook Multiple Band LigatorWilson-Cook Medical, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK020526 Modification to Wilson-Cook Multiple Band LigatorDon Wilson/Wilson-Cook Medical, Inc. · 2002
  3. Descendant · 2 generations on · 0 of its ownK060623 Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview AnoscopeCook Ireland, Ltd. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K020526Modification to Wilson-Cook Multiple Band LigatorDon Wilson/Wilson-Cook Medical, Inc. · 2002 · cites it directly1descendant
  • K060623Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview AnoscopeCook Ireland, Ltd. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944220Wilson Cook Multiple Band LigatorWilson-Cook Medical, Inc.1995—
+1K020526Modification to Wilson-Cook Multiple Band LigatorDon Wilson/Wilson-Cook Medical, Inc.2002—
+2K060623Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview AnoscopeCook Ireland, Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
FIG. 1 — Lineage of K944220, 1995–2006Source: 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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  • 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K020526Modification to Wilson-Cook Multiple Band LigatorDon Wilson/Wilson-Cook Medical, Inc.20021

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 3, 2010Not classifiedZ-0092-2011OtherA section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patient's gastrointestinal…
Jan 15, 2004Not classifiedZ-0536-04OtherProduct label lacks the symbols specifying the meaning of the manufacturing and expiration date.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K020526 (Don Wilson/Wilson-Cook Medical, Inc., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MND devices

MND Ligator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MND

1in 2013

2008: 12009: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MND

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

Recalls per year · MND

1in 2025

2010: 12011: 12020: 12025: 1, 1 Class I
2007high 1 (2010) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MND

1,083in 2025

2007: 842008: 4512009: 1,1612010: 6002011: 6722012: 7192013: 7502014: 1172015: 762016: 942017: 882018: 1242019: 2942020: 3452021: 6742022: 8082023: 6892024: 9212025: 1,083
2007high 1,161 (2009) · low 76 (2015)2025

MAUDE reports naming product code MND, 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—084
20081—0451
20091—01,161
20100—1600
20110—1672
20120—0719
20131—0750
20140—0117
20150—076
20160—094
20170—088
20180—0124
20190—0294
20200—1345
20210—0674
20220—0808
20230—0689
20240—0921
20250—1 (1)1,083
20260—0—
Cite this page

510(k) Report. “K944220: Wilson Cook Multiple Band Ligator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944220

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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