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Japan Gas Company Limited: FDA-registered device maker in YOKOHAMA Kanagawa, Japan, 3 510(k) clearances

Name: Japan Gas Company Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Japan Gas Company Limited is registered with the FDA (registration 3010188783) in YOKOHAMA Kanagawa, Japan. It lists 16 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 16, 2014. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3010188783
Address: 2-7, Daikokucho, Tsurumi-Ku, YOKOHAMA Kanagawa, Japan, 230-0053
Owner or operator: JAPAN GAS COMPANY LIMITED (10042580)
Roles: Contract sterilizer, Manufacturer
First device listed: December 10, 2012
Registered through: 2026
Brand names listed: CAPSULE ENDSCOPE SYSTEM, GM-30 Inflation Device, GOODTEC Y-CONNECTOR SET, KD-V441M, SINGLE USE SPLINTING TUBE, Single Use 3-Lumen Needle Knife V DISPOSABLE ELECTROSURGICAL SNARE, Single Use 3-Lumen Sphincterotome V, Single Use Aspiration Needle and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Contract sterilizer	accessdata.fda.gov
Biopsy Needle	FCG	2	Contract sterilizer	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Contract sterilizer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract sterilizer	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Contract sterilizer	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Contract sterilizer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Contract sterilizer	accessdata.fda.gov
Enteroscope And Accessories	FDA	2	Contract sterilizer	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Contract sterilizer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Contract sterilizer	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Contract sterilizer	accessdata.fda.gov
Ligator, Esophageal	MND	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Contract sterilizer	accessdata.fda.gov
System, Imaging, Gastrointestinal, Wireless, Capsule	NEZ	2	Contract sterilizer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Contract sterilizer	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
October 16, 2014	K142618	Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System	ITX	Substantially Equivalent	Hitachi Aloka Medical America, Inc.	accessdata.fda.gov
June 11, 2014	K140854	INTRA-OPERATIVE ULTRASOUND TRANSDUCER	ITX	Substantially Equivalent	Hitachi Aloka Medical, Ltd.	accessdata.fda.gov
December 11, 2001	K013066	HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE	MND	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 16, 2014. 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.