Data / Medical devices / South Korea / The Standard Co., Ltd.

The Standard Co., Ltd.: FDA-registered device maker in Gunpo-si Gyeonggi, South Korea, 2 510(k) clearances

Name: The Standard Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Standard Co., Ltd. is registered with the FDA (registration 3013734919) in Gunpo-si Gyeonggi, South Korea. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 3, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013734919
Address: 120, Gunpocheomdansaneop 2-ro, Gunpo-si Gyeonggi, South Korea, 15880
Owner or operator: The Standard Co., Ltd. (10055479)
Roles: Contract sterilizer, Manufacturer
First device listed: July 28, 2017
Registered through: 2026
Brand names listed: A-FIT, ACUNAV Luxera 4D ICE Catheter, ASCENDO submucosal lifting agent-10mL (Model Name : 00712935), ASCENDO submucosal lifting agent-5mL (Model Name : 00712934), AcuNav 10F ultrasound catheter, AcuNav 10F ultrasound catheter (GE), AcuNav 8F ultrasound catheter, AcuNav 8F ultrasound catheter (GE) and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Ultrasound, Intravascular	OBJ	2	Contract sterilizer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract sterilizer	accessdata.fda.gov
Marker, Colon	NBG	2	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Contract sterilizer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract sterilizer	accessdata.fda.gov
Submucosal Injection Agent	PLL	2	Manufacturer	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
July 3, 2024	K241591	Blue Eye	PLL	Substantially Equivalent	The Standard Co., Ltd.	accessdata.fda.gov
August 12, 2022	K220434	Blue Eye (TS-905)	PLL	Substantially Equivalent	The Standard Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 3, 2024. 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.