Horizons Intl. Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Horizons Intl. Corp.” (first 2001, latest 2008), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FDI | Snare, Flexible | 3 | 3 |
| KGE | Forceps, Biopsy, Electric | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
Review panels
Most recent Horizons Intl. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083049 | TORNADO ROTATABEL SNARE AND POLYP CATCHER | FDI | 2008-12-23 | 70 |
| K022268 | HORIZONS REUSABLE POLYPECTOMY SNARES | FDI | 2002-10-25 | 102 |
| K022243 | HORIZONS REUSABLE HOT BIOPSY FORCEPS | KGE | 2002-10-25 | 105 |
| K022546 | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES | EOQ | 2002-08-12 | 11 |
| K021998 | HORIZONS CYTOLOGY BRUSH | FDX | 2002-07-12 | 23 |
| K021706 | HORIZONS HOT BIOPSY FORCEPS | KGE | 2002-06-21 | 29 |
| K011667 | HORIZONS INTERNATIONAL POLYPECTOMY SNARES | FDI | 2001-08-16 | 78 |
| K010448 | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | FBK | 2001-05-16 | 90 |
| K002236 | HORIZONS PAPILLOTOME | KNS | 2001-01-23 | 183 |
| K002235 | HORIZONS ERCP CANNULA | FGE | 2001-01-23 | 183 |
Recalls
openFDA lists no recalls under a recalling firm named Horizons Intl. Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Horizons Intl. Corp.?
FDA lists 10 510(k) clearances under the applicant name “Horizons Intl. Corp.” (first 2001, latest 2008), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Horizons Intl. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Horizons Intl. Corp. is 84 days.
Which FDA product codes appear under Horizons Intl. Corp.?
The most frequent FDA product codes under this applicant name are FDI (Snare, Flexible, 3); KGE (Forceps, Biopsy, Electric, 2); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 10 Horizons Intl. Corp. clearances with predicates and recalls
- Run predicate analysis for product code FDI, Horizons Intl. Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.