Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004083736

FEI Number

3004083736

Entity Name

HORIZONS INTL. CORP.

City/State/Country

HEREDIA, CR

Establishment Address

ZETA FREE ZONE PARK, LA VALENCIA, HEREDIA --, CR

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HORIZONS INTL. CORP. (Owner Number: 9040535)

Owner / Operator Contact Address

ZETA FREE ZONE PARK, LA VALENCIA, HEREDIA, CR-NOTA --, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TWISTER PLUS RETRIEVAL DEVICE Horizons International Polypectomy Horizons Reusable Polypectomy Snare Horizons International Varices Inje Horizons Reusable Hot Biopsy Forcep Horizons ANSO TransBronchial Aspira Horizons Hot Biopsy Forceps COBRA ROTATABEL SNARE AND POLYP C TORNADO ROTATABEL SNARE AND POLYP C Horizons Cleaning Brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2009-04-01
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2007-12-04
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-12-04
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2007-12-04
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-12-04
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2007-12-04
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2007-12-04
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2007-12-04
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2009-01-07
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2007-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

Miriam Oliveras Business: Miriam Oliveras Email: miriam.oliveras@gmail.com Phone: (787) 2989967

Related Public Records

Same Entity

HORIZONS INTL. CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2016	US Endoscopy Group Inc	2	Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004083736. Last updated year: 2026. Please use registration number 3004083736 when referencing this establishment in official correspondence.