510(k) · Cleared
ClearedLigation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leo Medical Co., Ltd. · FHN Ligator, Hemorrhoidal
Cleared on Jun 14, 2018 as substantially equivalent to K964661 (Olympus America, Inc., 1997) after a 260-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jun 14, 2018
- Review
- 260 days
- Class
- Class II
- Product code
- FHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964661 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964661 HX-20/21-1 Endoscopic LigatorOlympus America, Inc. · 1997
- This deviceK172985 Ligation DeviceLeo Medical Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964661 | HX-20/21-1 Endoscopic Ligator | Olympus America, Inc. | 1997 | — |
| 0 (this device) | K172985 | Ligation Device | Leo Medical Co., Ltd. | 2018 | — |
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? (1)
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 |
|---|---|---|---|
| * | K964661 | HX-20/21-1 Endoscopic LigatorSummary page 5…e two components provided in different sizes to consist different specifications of ligation device. 4. Identification of Predicate Device 510(k) Number: K964661 Product Name: Olympus HX-20-1 Endoscopic Ligator 5. Non-Clinical Test Conclusion Non clinical tests were conducte… | 1997 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K964661.
How does its category compare?
All FHN devicesFHN Ligator, Hemorrhoidal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
The device is designed to be used with an Endoscope to deliver a Ligation Loop designed to prevent or control bleeding
following polypectomy of pedunculated polyps.
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/K172985 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172985: Ligation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172985
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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