Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003713161

FEI Number

3003713161

Entity Name

MITAKA KOHKI CO., LTD.

City/State/Country

MITAKA SHI Tokyo, JP

Establishment Address

1-18-8 Nozaki, MITAKA SHI Tokyo 181-0014, JP

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MITAKA KOHKI CO., LTD. (Owner Number: 9035807)

Owner / Operator Contact Address

1-18-8 Nozaki, --, MITAKA SHI, TOKYO, JP-NOTA 181-0014, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Point Setter Mitaka OH5 Mitaka KestrelView Mitaka OH6 Mitaka MM51 YOH Mitaka KestrelView II Mitaka OH4 Mitaka MM80 SS1 Mitaka MM51 SS1 Mitaka MM80 YOH Mitaka MM90 SOH Mitaka MM80 SOH Mitaka MM90 YOH HawkSight Mitaka MM77 SOH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-11-19
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2016-02-08

Official Correspondent

No official correspondent registered.

US Agent Details

Maxwell Sturgis Business: Mitaka USA, Inc. Email: acs@mitakausa.com Phone: (435) 9010515

Related Public Records

Same Entity

MITAKA KOHKI 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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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3021744308	Lazurite Inc.	Cleveland, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003713161. Last updated year: 2026. Please use registration number 3003713161 when referencing this establishment in official correspondence.