Data / Medical devices / Costa Rica / Horizons Intl. Corp.
Horizons Intl. Corp.: FDA-registered device maker in Heredia, Costa Rica, 9 510(k) clearances
Horizons Intl. Corp. is registered with the FDA (registration 3004083736) in Heredia, Costa Rica. It lists 11 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 23, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004083736
- Address
- Zeta Free Zone Park La Valencia, Heredia, Costa Rica, --
- Owner or operator
- HORIZONS INTL. CORP. (9040535)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler
- First device listed
- February 28, 2000
- Registered through
- 2026
- Brand names listed
- ANSO TBNA, ANSO Triple Needle Brush, Biopsy Forceps, COBRA ROTATABEL SNARE AND POLYP C, Cytology Brush, HORIZONS BIOPSY FORCEP, HORIZONS ENDOSCOPI, Horizons ANSO TransBronchial Aspira and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Cytology Brush | FDX | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Electric | KGE | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Snare, Flexible | FDI | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Snare, Non-Electrical | FGX | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2008 | K083049 | TORNADO ROTATABEL SNARE AND POLYP CATCHER | FDI | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
| October 25, 2002 | K022268 | HORIZONS REUSABLE POLYPECTOMY SNARES | FDI | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
| October 25, 2002 | K022243 | HORIZONS REUSABLE HOT BIOPSY FORCEPS | KGE | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
| August 12, 2002 | K022546 | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES | EOQ | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
| July 12, 2002 | K021998 | HORIZONS CYTOLOGY BRUSH | FDX | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
| June 21, 2002 | K021706 | HORIZONS HOT BIOPSY FORCEPS | KGE | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
| August 16, 2001 | K011667 | HORIZONS INTERNATIONAL POLYPECTOMY SNARES | FDI | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
| May 16, 2001 | K010448 | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | FBK | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
| January 23, 2001 | K002236 | HORIZONS PAPILLOTOME | KNS | Substantially Equivalent | Horizons Intl. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- All makers of System, X-Ray, Tomography, Computed
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
- All makers of Snare, Flexible
- All makers of Forceps, Biopsy, Non-Electric
Updated December 23, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.