Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000160970

FEI Number

3000160970

Entity Name

IKEGAMI TSUSHINKI CO., LTD.

City/State/Country

Utsunomiya Tochigi, JP

Establishment Address

41-2 Hiraide Kogyo Danchi, Utsunomiya Tochigi 321-0905, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ikegami tsushinki Co., Ltd. (Owner Number: 10055510)

Owner / Operator Contact Address

41-2 Hiraide Kogyo Danchi, Utsunomiya, JP-09 321-0905, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MLW-2623C-DC MLW-2750UHD MLW-2170HD F88 Flexible Camera Control Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2017-08-03
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-04

Official Correspondent

nobuyuki nakajima

US Agent Details

Toshihisa Mitsuoka Business: Ikegami Electronics (USA) Inc Email: tmitsuoka@ikegami.com Phone: (201) 3689171

Related Public Records

Same Entity

Ikegami tsushinki 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
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 3000160970. Last updated year: 2026. Please use registration number 3000160970 when referencing this establishment in official correspondence.