510(k) · Cleared
ClearedShortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview Anoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FER Anoscope And Accessories
Cleared on Sep 6, 2006 as substantially equivalent to K020526 (Don Wilson/Wilson-Cook Medical, Inc., 2002) and 1 other predicate after a 182-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 6, 2006
- Review
- 182 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944220 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK944220 Wilson Cook Multiple Band LigatorWilson-Cook Medical, Inc. · 1995 · Recalled
- 1 generation backK020526 Modification to Wilson-Cook Multiple Band LigatorDon Wilson/Wilson-Cook Medical, Inc. · 2002
- This deviceK060623 Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview AnoscopeCook Ireland, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944220 | Wilson Cook Multiple Band Ligator | Wilson-Cook Medical, Inc. | 1995 | 2 |
| −1 | K020526 | Modification to Wilson-Cook Multiple Band Ligator | Don Wilson/Wilson-Cook Medical, Inc. | 2002 | — |
| 0 (this device) | K060623 | Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview Anoscope | Cook Ireland, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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 FER? 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 FER device
- #1 K250645 SleeveLUX 24 Anoscope/Proctoscope (P2001)…score 10.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K020526 | Modification to Wilson-Cook Multiple Band LigatorSummary page 1…Ligator, Hemorrhoidal, GU, 78FHN Anoscope, Non Powered, GU, FER Legally Marketed Devices: Wilson-Cook Multiple Band Ligator (K020526) O'Regan Disposable Anoscope (K020702) Description of the Device: The ShortShot Saeed Hemorrhoid… | 2002 |
| * | K020702 | O'regan Disposable AnoscopeSummary page 1…Anoscope, Non Powered, GU, FER Legally Marketed Devices: Wilson-Cook Multiple Band Ligator (K020526) O'Regan Disposable Anoscope (K020702) Description of the Device: The ShortShot Saeed Hemorrhoidal Multi- Band Ligator consists of a p… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FER
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FER
Too few FER 510(k)s in any year since 2007 to give a median.
Recalls per year · FER
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FER
3in 2025
MAUDE reports naming product code FER, 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 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ShortShot Saeed Hemorrhoidal MultiBand Ligator with TriView Anoscope is used to
ligate internal hemorrhoids facilitated by an anoscope, for use in aduli patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060623: Shortshot Saeed Hemorrhoidal Multi-Band Ligator with Triview Anoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060623
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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