Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010188783

FEI Number

3010188783

Entity Name

JAPAN GAS COMPANY LIMITED

City/State/Country

YOKOHAMA Kanagawa, JP

Establishment Address

2-7, DAIKOKUCHO, TSURUMI-KU, YOKOHAMA Kanagawa 230-0053, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

JAPAN GAS COMPANY LIMITED (Owner Number: 10042580)

Owner / Operator Contact Address

2-7, DAIKOKUCHO, TSURUMI-KU, YOKOHAMA, JP-14 230-0053, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single Use Aspiration Needle Single Use Repositionable Clip Single Use Injector DISPOSABLE INJECTOR NM SINGLE USE SPLINTING TUBE Single Use Rotatable Clip Fixing Device GOODTEC Y-CONNECTOR SET KD-V441M Single Use 3-Lumen Sphincterotome V UST-5311-TIP UST-5310 UST-5310-TIP UST-5311 Single Use 3-Lumen Needle Knife V DISPOSABLE ELECTROSURGICAL SNARE THUNDERBEAT SONICBEAT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-12-18
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2015-12-18
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2024-04-10
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2024-04-10
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2024-04-10
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2015-12-18
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2012-12-10
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2012-12-10
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2012-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-04-10
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2024-04-10
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2015-12-18
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2024-04-10
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2025-03-24
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2015-12-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-08-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-04-10
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2024-04-10
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-10
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2012-12-10
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-12-10

Official Correspondent

Hisayoshi Nakamoto

US Agent Details

Todd Brill Business: Gyrus ACMI, Inc. Email: todd.brill@olympus.com Phone: (508) 2077661

Related Public Records

Same Entity

JAPAN GAS COMPANY LIMITED

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
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
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

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.
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 3010188783. Last updated year: 2026. Please use registration number 3010188783 when referencing this establishment in official correspondence.