Medical Device Manufacturer · CN , Suzhou

Suzhou Haishen Medical Device Associates Co., Ltd.

2 submissions · 2 cleared · Since 2023

Total

Cleared

Denied

Suzhou Haishen Medical Device Associates Co., Ltd. — FDA 510(k) Submissions

Suzhou Haishen Medical Device Associates Co., Ltd. has submitted 2 FDA 510(k) premarket notifications since 2023, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Needle, Stimulator, Nerve . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

Disposable Laryngeal Electrodes

K232888 · ETN Stimulator, Nerve · Ear, Nose, Throat

Dec 2023 94d

Medical Disposable Sterile Needle Electrode

K232581 · GXZ Electrode, Needle · Neurology

Dec 2023 101d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Suzhou Haishen Medical Device Associates Co., Ltd.

Suzhou Haishen Medical Device Associates Co., Ltd. — FDA 510(k) Submissions

Filters