Medical Device Manufacturer · JP , Tochigi-Ken

Tsk Laboratory, Japan - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1997

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tsk Laboratory, Japan General Hospital ✕

3 devices

1-3 of 3

Cleared Jul 30, 2025

General Hospital · 194d

Cleared Jul 24, 2025

TSK SELECT™ Needle

General Hospital · 174d

Cleared Apr 10, 1997

TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

General Hospital · 69d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026