510(k) · Cleared
ClearedModification to Auto-Band Ligator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scandimed International · MND Ligator, Esophageal
Cleared on Feb 19, 2009 as substantially equivalent to K031236 (Scandimed. A.S., 2003) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Feb 19, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- MND
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K031236 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK031236 Auto-Band LigatorScandimed. A.S. · 2003
- 1 generation backK081142 Auto-Band LigatorScandimed International · 2008
- This deviceK083556 Modification to Auto-Band LigatorScandimed International · 2009
- Descendant · cites it directly · 0 of its ownK132535 Autoband LigatorEndochoice, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132535Autoband LigatorEndochoice, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031236 | Auto-Band Ligator | Scandimed. A.S. | 2003 | — |
| −1 | K081142 | Auto-Band Ligator | Scandimed International | 2008 | — |
| 0 (this device) | K083556 | Modification to Auto-Band Ligator | Scandimed International | 2009 | — |
| +1 | K132535 | Autoband Ligator | Endochoice, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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.
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
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031236 | Auto-Band LigatorSummary page 1…ude 6 and 8 band variations. The predicate device used to determine substantial equivalence for this device was the Scandimed International Auto-Band Ligator (#K031236 and #K081142). 4. DEVICE DESCRIPTION: The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a sco… | 2003 |
| * | K081142 | Auto-Band LigatorSummary page 1…and variations. The predicate device used to determine substantial equivalence for this device was the Scandimed International Auto-Band Ligator (#K031236 and #K081142). 4. DEVICE DESCRIPTION: The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixat… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132535 | Autoband Ligator | 2013 | 0 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132535 (Endochoice, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031236.
How does its category compare?
All MND devicesMND Ligator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MND
1in 2013
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
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MND
1,083in 2025
MAUDE reports naming product code MND, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 84 |
| 2008 | 1 | — | 0 | 451 |
| 2009 | 1 | — | 0 | 1,161 |
| 2010 | 0 | — | 1 | 600 |
| 2011 | 0 | — | 1 | 672 |
| 2012 | 0 | — | 0 | 719 |
| 2013 | 1 | — | 0 | 750 |
| 2014 | 0 | — | 0 | 117 |
| 2015 | 0 | — | 0 | 76 |
| 2016 | 0 | — | 0 | 94 |
| 2017 | 0 | — | 0 | 88 |
| 2018 | 0 | — | 0 | 124 |
| 2019 | 0 | — | 0 | 294 |
| 2020 | 0 | — | 1 | 345 |
| 2021 | 0 | — | 0 | 674 |
| 2022 | 0 | — | 0 | 808 |
| 2023 | 0 | — | 0 | 689 |
| 2024 | 0 | — | 0 | 921 |
| 2025 | 0 | — | 1 (1) | 1,083 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon.
For single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083556: Modification to 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/K083556
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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