Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014766734

FEI Number

3014766734

Entity Name

FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant

City/State/Country

Shirakawa Fukushima, JP

Establishment Address

1-23 Tsukinoiri, Kayane, Shirakawa Fukushima 961-0004, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUJI SYSTEMS CORPORATION (Owner Number: 9052600)

Owner / Operator Contact Address

23-14, HONGO 3-CHOME, BUNKYO-KU, --, TOKYO, JP-13 113-0033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K894337

PMA Number

N/A

All Registered Proprietary Names

CELLO Balloon Guide Catheter; 6F, 7F, 8F, 9F Wire Reinforced Endotracheal Tube Univent Tube 7mm, 7.5mm, 8mm, 8.5mm, 9mm Silbroncho Double Lumen Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2008-07-17
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2008-07-17
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-07-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-08-21
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2008-08-26
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2008-08-26

Official Correspondent

No official correspondent registered.

US Agent Details

Gregory Geissinger Email: greg@geissingerreg.com Phone: (858) 3498839

Related Public Records

Same Entity

FUJI SYSTEMS CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3000308637	FUJI SYSTEMS CORPORATION, Shirakawa Plant	Nishi Shirakawa Gun Fukushima, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K904800	Olympus Corp.	SIF-SW	1991-03-27
K233321	FUJIFILM Healthcare Americas Corporation	Double Balloon Endoscope EN-840T, Over-tube TS-1214C	2024-06-13
K251204	FUJIFILM Healthcare Americas Corporation	FUJIFILM Stiffening Wire Device (SW-2000)	2025-09-26
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3006161756	FUJIFILM Healthcare Manufacturing Corporation Sano Office	Sano City Tochigi, JP
3008386005	IAN JAMIESON PTY LTD	Fyshwick Australian Capital Territory, AU
3033902430	OMEC THAI CO.,LTD.	Bang Bo District Samut Prakan, TH
3002808148	SHIRAKAWA OLYMPUS CO., LTD.	NISHISHIRAKAWA-GUN Fukushima, JP
2936485	STRYKER ENDOSCOPY	SAN JOSE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014766734. Last updated year: 2026. Please use registration number 3014766734 when referencing this establishment in official correspondence.