510(k) · Cleared
ClearedO'regan Ligator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patrick J. O'Regan · FHN Ligator, Hemorrhoidal
Cleared on May 5, 1997 after a 264-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- May 5, 1997
- Review
- 264 days
- Class
- Class II
- Product code
- FHN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK963166 O'regan LigatorPatrick J. O'Regan · 1997
- Descendant · cites it directly · 4 of its ownK070881 Lem Hemorrhoidal Ligator, Models a.5650, a.5660Sapimed S.P.A. · 2007
- Descendant · 2 generations on · 3 of its ownK091519 Haemoband Multi-LigatorHaemoband Surgical, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK131282 Nexus Hemorrhoid LigatorInx Medical · 2013
- Descendant · 2 generations on · 0 of its ownK150718 Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK093497 THD BandyThd Spa · 2010
Most influential descendants
Showing 5 of 5 · See all- K070881Lem Hemorrhoidal Ligator, Models a.5650, a.5660Sapimed S.P.A. · 2007 · cites it directly4descendants
- K091519Haemoband Multi-LigatorHaemoband Surgical, Ltd. · 2009 · 2 generations on3descendants
- K131282Nexus Hemorrhoid LigatorInx Medical · 2013 · cites it directly1descendant
- K150718Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015 · 2 generations on0descendants
- K093497THD BandyThd Spa · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963166 | O'regan Ligator | Patrick J. O'Regan | 1997 | — |
| +1 | K070881 | Lem Hemorrhoidal Ligator, Models a.5650, a.5660 | Sapimed S.P.A. | 2007 | — |
| +2 | K091519 | Haemoband Multi-Ligator | Haemoband Surgical, Ltd. | 2009 | — |
| +1 | K131282 | Nexus Hemorrhoid Ligator | Inx Medical | 2013 | — |
| +2 | K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015 | — |
| +2 | K093497 | THD Bandy | Thd Spa | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 FHN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FHN device
- #1 K213223 Multi-Band Ligatorscore 3.5 · 1 generation · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K070881 (Sapimed S.P.A., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FHN devicesFHN Ligator, Hemorrhoidal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FHN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FHN
Too few FHN 510(k)s in any year since 2007 to give a median.
Recalls per year · FHN
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FHN
7in 2025
MAUDE reports naming product code FHN, 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 | 1 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 1 | — | 2 | 3 |
| 2010 | 1 | — | 1 | 17 |
| 2011 | 0 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 102 |
| 2014 | 0 | — | 0 | 208 |
| 2015 | 1 | — | 0 | 228 |
| 2016 | 0 | — | 0 | 202 |
| 2017 | 0 | — | 0 | 303 |
| 2018 | 1 | — | 0 | 318 |
| 2019 | 0 | — | 0 | 372 |
| 2020 | 0 | — | 0 | 70 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 0 | — | 0 | 47 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This ligator is intended to be used only as a hemorrhoid ligator.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963166: O'regan Ligator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963166
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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