Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012854006

FEI Number

3012854006

Entity Name

TSK LABORATORY, JAPAN

City/State/Country

TOCHIGI-SHI, JP

Establishment Address

1510-1 SOJA-MACHI, TOCHIGI-SHI 328-0002, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

TSK LABORATORY, JAPAN (Owner Number: 9008437)

Owner / Operator Contact Address

1510-1 Soja-Machi, --, TOCHIGI-SHI, TOCHIGI-KEN, JP-09 328-0002, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K970370

PMA Number

N/A

All Registered Proprietary Names

CSH Cannula STERiGLIDE Sterijekt Steriject

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-01-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-07-16

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

TSK LABORATORY, JAPAN

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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
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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1058584	Sterigenics US LLC	Charlotte, NC, US
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012854006. Last updated year: 2026. Please use registration number 3012854006 when referencing this establishment in official correspondence.