FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 2 results

510(k) Data Aggregation

K Number

Device Name

TSK SELECT Needle

Manufacturer

TSK Laboratory, Japan

Date Cleared

2025-07-24

(174 days)

Product Code

FMI

Regulation Number

880.5570

Why did this record match?

Applicant Name (Manufacturer) :

TSK Laboratory, Japan

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

K Number

Device Name

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

Manufacturer

TSK LABORATORY, JAPAN

Date Cleared

1997-04-10

(69 days)

Product Code

FMI

Regulation Number

880.5570

Why did this record match?

Applicant Name (Manufacturer) :

TSK LABORATORY, JAPAN

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.

Device Description

TSK STERIJEKT is a sterile Hypodermic Single Lumen Needle, packaged individually for single patient use. It consists of a stainless steel beveled cannula bonded to a plastic hub. Sizes include 14G-31G and various lengths. The needle is intended to fit any luer lock or luer slip syringe tip.

Ask a Question

Page 1 of 1