Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008456389

FEI Number

3008456389

Entity Name

Kitazato Corporation

City/State/Country

Minato-ku Tokyo, JP

Establishment Address

1-1-8 Shibadaimon, Minato-ku Tokyo 105-0012, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Kitazato Corporation (Owner Number: 10045322)

Owner / Operator Contact Address

1-1-8 Shibadaimon, Minato-ku, JP-13 105-0012, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112462

PMA Number

N/A

All Registered Proprietary Names

Stylet for Guide (EC-PRO Stylet) Echogenic Catheter 4.7Fr(EC-PRO Master) Trial Catheter 4.7Fr Supported (Trial EC-PRO Supported) Trial Catheter 4.7Fr (Trial EC-PRO) Catheters 4.7Fr(EC-PRO) Echogenic Trial Catheter 4.7Fr(Trial EC-PRO Master) Catheter 4.7Fr Supported (EC-PRO Supported) Echogenic Trial Catheter 4.7Fr Supported (Trial EC-PRO Master Supported) Echogenic Catheter 4.7Fr Supported (EC-PRO Master Supported) Catheter 3Fr or 4Fr and Guide Catheter 3Fr or 4Fr and Guide with Obturator Catheter 3Fr or 4Fr Stylet for Guide Kitazato OPU Reduced Needle (model number Type3) Kitazato OPU Needle with Connection Tube (model number Type2) Kitazato OPU Two-Stage Reduced Needle (model number Type4) Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2 Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1 Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 10 cm, model number Type 5-v3 and Type 5-v4 Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 10 cm, model number Type 4-v3 and Type 4-v4 Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 18 cm, model number Type 5-v1 and Type 5-v2 Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 18 cm, model number Type 4-v1 and Type 4-v2 Kitazato OPU Reduced Needle, model number Type 3 Kitazato OPU Needle with Connection Tube, model number Type 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2017-07-28
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2020-05-08
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2017-07-28
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-11-05
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2017-05-19
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2013-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Kitazato Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008876063	KITAZATO CORPORATION	Fuji Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008456389. Last updated year: 2026. Please use registration number 3008456389 when referencing this establishment in official correspondence.