Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001595398

FEI Number

3001595398

Entity Name

Fujita Medical Instruments Co., Ltd

City/State/Country

Tokyo, JP

Establishment Address

3-6-1 Bunkyo-ku, Tokyo 113-0033, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Selective Surgical/Zimmer Biomet/FUJITA US POC (Owner Number: 10039585)

Owner / Operator Contact Address

Hongo 3-6-1, Bunkyo-ku, Tokyo, JP-13 113-0033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fujita Rongeur Fujita Retractor Fujita Suction Fujita Scissors Fujita Forceps Fujita Elevator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2012-08-10
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-05-11
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2012-01-25
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-05-11
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-05-11
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-05-11

Official Correspondent

Mike Amos

US Agent Details

Mike Amos Email: mikeamos@carolina.rr.com Phone: (704) 6514954

Related Public Records

Same Entity

Selective Surgical/Zimmer Biomet/FUJITA US POC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001595398. Last updated year: 2026. Please use registration number 3001595398 when referencing this establishment in official correspondence.