510(k) Report

510(k) · Cleared

Cleared

Auto-Band Ligator

K031236510(k) TraditionalCleared Nov 14, 2003210-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

Scandimed. A.S. · MND Ligator, Esophageal

Cleared on Nov 14, 2003 after a 210-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided
Nov 14, 2003
Review
210 days
Class
Class II
Product code
MND
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2008: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK031236 Auto-Band LigatorScandimed. A.S. · 2003
  2. Descendant · cites it directly · 2 of its ownK081142 Auto-Band LigatorScandimed International · 2008
  3. Descendant · cites it directly · 1 of its ownK083556 Modification to Auto-Band LigatorScandimed International · 2009
  4. Descendant · 2 generations on · 0 of its ownK132535 Autoband LigatorEndochoice, Inc. · 2013

Most influential descendants

Showing 3 of 3 · See all
  • K081142Auto-Band LigatorScandimed International · 2008 · cites it directly2descendants
  • K083556Modification to Auto-Band LigatorScandimed International · 2009 · cites it directly1descendant
  • K132535Autoband LigatorEndochoice, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031236Auto-Band LigatorScandimed. A.S.2003—
+1K081142Auto-Band LigatorScandimed International2008—
+1K083556Modification to Auto-Band LigatorScandimed International2009—
+2K132535Autoband LigatorEndochoice, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201310
FIG. 1 — Lineage of K031236, 2003–2013Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MND? 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K081142Auto-Band LigatorScandimed International20082
K083556Modification to Auto-Band LigatorScandimed International20091

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, K081142 (Scandimed International, 2008) has gone furthest, with 2 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—

What is it indicated for?

The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon.

For single use only.

Indications for use as stated in the FDA 510(k) statement.

More from Scandimed. A.S.

2 FDA decisions under this applicant name. See the company

  • K031238Varices NeedleScandimed. A.S. · 2004

Recent decisions in MND

The MND category page

  • K132535Autoband LigatorEndochoice, Inc. · 2013
  • K083556Modification to Auto-Band LigatorScandimed International · 2009
  • K081142Auto-Band LigatorScandimed International · 2008
  • K051950Inscope Multi-Clip Applier, Models IN22321, IN23321Ethicon Endo-Surgery, Inc. · 2005
  • K033245Bard Ultraview Multiple Band Ligator, Model 00700UC.R. Bard, Inc. · 2003

https://510kreport.com/device/K031236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031236: Auto-Band Ligator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031236

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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