FDA product code FHN: Ligator, Hemorrhoidal
FHN is the FDA product code for ligator, hemorrhoidal. It is a Class II device, regulated under 21 CFR 876.4400 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 22 510(k) submissions under FHN, 1 in the last five years, from 18 different applicants. The average 510(k) review took 116 days (median 88). FDA has posted 5 recalls for FHN devices.
Classification
| Field | Value |
|---|---|
| Device name | Ligator, Hemorrhoidal |
| Device class | Class II |
| Regulation | 21 CFR 876.4400 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for FHN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 260 |
| 2022 | 1 | 250 |
Compare with all 510(k) review times · Search every FHN clearance
Top FHN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 5 | 2002-04-12 |
| Beijing Zksk Technology Co., Ltd. | 1 | 2022-06-06 |
| Leo Medical Co., Ltd. | 1 | 2018-06-14 |
| Agency For Medical Innovations GmbH | 1 | 2015-06-12 |
| Inx Medical | 1 | 2013-07-11 |
13 more applicants have FHN clearances. See the full list in Caduvo.
Most recent FHN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213223 | Beijing Zksk Technology Co., Ltd. | Multi-Band Ligator | 2022-06-06 | 250 |
| K172985 | Leo Medical Co., Ltd. | Ligation Device | 2018-06-14 | 260 |
| K150718 | Agency For Medical Innovations GmbH | Wi-3 HAL-RAR System | 2015-06-12 | 85 |
| K131282 | Inx Medical | NEXUS HEMORRHOID LIGATOR | 2013-07-11 | 66 |
| K093497 | Thd Spa | THD BANDY | 2010-07-15 | 245 |
Recalls for FHN devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-07-19.
Frequently asked questions
What is FDA product code FHN?
FHN is the FDA product code for ligator, hemorrhoidal. It is a Class II device, regulated under 21 CFR 876.4400 and reviewed by the Gastroenterology and Urology panel.
What device class is FHN?
Class II, regulation 21 CFR 876.4400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FHN?
Across 22 cleared submissions the average was 116 days from receipt to decision (median 88).
Which companies have the most FHN clearances?
Boston Scientific Corp (5); Beijing Zksk Technology Co., Ltd. (1); Leo Medical Co., Ltd. (1); Agency For Medical Innovations GmbH (1); Inx Medical (1).
Have FHN devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2011-07-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FHN
- Run a recall and safety report across every FHN manufacturer
- Watch product code FHN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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