510(k) Report

510(k) · Cleared

Cleared

Stiegmann-Goff Endoscopic Ligator

K940661510(k) TraditionalCleared Nov 28, 1994286-day reviewClass II21 CFR 876.4400

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

C.R. Bard, Inc. · MND Ligator, Esophageal

Cleared on Nov 28, 1994 after a 286-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Nov 28, 1994
Review
286 days
Class
Class II
Product code
MND
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK940661 Stiegmann-Goff Endoscopic LigatorC.R. Bard, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK971137 Bard Rapidfire Multiple Band LigatorC.R. Bard, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K971137Bard Rapidfire Multiple Band LigatorC.R. Bard, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940661Stiegmann-Goff Endoscopic LigatorC.R. Bard, Inc.1994—
+1K971137Bard Rapidfire Multiple Band LigatorC.R. Bard, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K940661, 1994–1997Source: 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K971137Bard Rapidfire Multiple Band LigatorC.R. Bard, Inc.19970

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, K971137 (C.R. Bard, Inc., 1997) has gone furthest, with 0 descendants 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. “K940661: Stiegmann-Goff Endoscopic Ligator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940661

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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