Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032578846

FEI Number

3032578846

Entity Name

DYNE MEDICAL GROUP INC.

City/State/Country

Gimpo- si Gyeonggi, KR

Establishment Address

#1001-1013, #1015-1016, #1024-1025, 10F, 165, Gimpohangang 10-ro 133beon-gil,, Gimpo- si Gyeonggi 10071, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DYNE Medical Group Inc. (Owner Number: 10091398)

Owner / Operator Contact Address

#1001, 10F, 165, Gimpohangang 10-ro 133beon-gil, Gimpo- si, KR-41 10071, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240203

PMA Number

N/A

All Registered Proprietary Names

URUS System URUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-20

Official Correspondent

No official correspondent registered.

US Agent Details

Joyce Kwon Business: Provision Consulting Group, Inc. Email: ask@provisionfda.com Phone: (909) 4933276

Related Public Records

Same Entity

DYNE Medical Group Inc.

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
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032578846. Last updated year: 2026. Please use registration number 3032578846 when referencing this establishment in official correspondence.