Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043585886

FEI Number

3043585886

Entity Name

ONEPASS MEDICAL LTD

City/State/Country

Katzrin Northern, IL

Establishment Address

1st The Four street, Katzrin Industrial Park, Katzrin Northern 1290000, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OnePass Medical Ltd (Owner Number: 10095214)

Owner / Operator Contact Address

1st The Four street, Katzrin Industrial Park, Katzrin, IL-Z 1290000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251542

PMA Number

N/A

All Registered Proprietary Names

InstaFAN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-02-07
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2026-02-07

Official Correspondent

Jacob Ben Arie

US Agent Details

Christine Scifert Business: MRC Global, LLC Email: christine.scifert@askmrcglobal.com Phone: (901) 8318053

Related Public Records

Same Entity

OnePass Medical Ltd

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
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

Similar Registrations

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3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP
9611680	RADIA INDUSTRY CO., LTD.	Takasaki Gunma, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043585886. Last updated year: 2026. Please use registration number 3043585886 when referencing this establishment in official correspondence.