Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681387

FEI Number

3002808401

Entity Name

TSK Laboratory International Japan KK

City/State/Country

Tochigi, JP

Establishment Address

2 Chome 1-5, Hirayanagi-Machi, Tochigi 328-0012, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TSK Laboratory International Japan KK (Owner Number: 10083590)

Owner / Operator Contact Address

2-1-5 Hirayanagi-Cho, Tochigi, JP-09 328-0012, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K970370

PMA Number

N/A

All Registered Proprietary Names

STERiJECT Ophthalmic Needle STERiJECT Ophthalmic Needle Low Dead Space (LDS) FOURTE Expander Fill System STERiJECT Low Dead Space STERiJECT The Invisible Needle STERiJECT STERiJEKT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QYM	Ophthalmic Needle	General Hospital	Class 2	880.5570	2024-11-14
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2021-12-03
QNS	Low Dead Space Needle, Single Lumen, Hypodermic	General Hospital	Class 2	880.5570	2024-11-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-20

Official Correspondent

Norman Johnson

US Agent Details

Norman Johnson Business: Johnson Global California LLC Email: shane@tsklab.com Phone: (714) 7140294

Related Public Records

Same Entity

TSK Laboratory International Japan KK

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
K161483	Stradis Healthcare	Unger Quad Injector	2016-10-31
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681387. Last updated year: 2026. Please use registration number 9681387 when referencing this establishment in official correspondence.