Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013734919

FEI Number

3013734919

Entity Name

THE STANDARD CO., LTD.

City/State/Country

Gunpo-si Gyeonggi, KR

Establishment Address

120, Gunpocheomdansaneop 2-ro, Gunpo-si Gyeonggi 15880, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

The Standard Co., Ltd. (Owner Number: 10055479)

Owner / Operator Contact Address

120, Gunpocheomdansaneop 2-ro, Gunpo-si, KR-41 15880, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SILKRO ASCENDO submucosal lifting agent-10mL (Model Name : 00712935) ASCENDO submucosal lifting agent-5mL (Model Name : 00712934) Blue Eye (TS-910) SOUNDSTAR 3D G (SNDSTR10G) AcuNav 8F ultrasound catheter AcuNav 10F ultrasound catheter AcuNav 8F ultrasound catheter (GE) AcuNav 10F ultrasound catheter (GE) Acunav Crystal Ultrasound Catheter SILKRO SOUNDSTAR 3D (SNDSTR10) SOUNDSTAR eco 8F (10439011) & 8F G (10439236) SOUNDSTAR eco 10F (10438577) & 10F G (10439072) Black Eye Endoscopic Marker (Model Name : 00711836)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-10
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2024-07-04
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2022-09-05
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2022-08-31
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2023-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-10
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2022-09-05
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2022-09-05
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2022-09-05
NBG	Marker, Colon	Gastroenterology, Urology	Class 2	876.1500	2017-07-28

Official Correspondent

Boyeon Cho

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

The Standard Co., 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0003-2016	Biosense Webster, Inc.	2	SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

Similar Registrations

Registration Number	Establishment Name	Location
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013734919. Last updated year: 2026. Please use registration number 3013734919 when referencing this establishment in official correspondence.