Medical Device Manufacturer · CN , Beijing

Beijing Zksk Technology Co., Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2022

Recent clearances: Disposable Sphincterotome, Disposable Hot Biopsy Forceps, Disposable hemoclip

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Beijing Zksk Technology Co., Ltd. Gastroenterology & Urology ✕

6 devices

1-6 of 6

Cleared Feb 06, 2025

Disposable Sphincterotome

Gastroenterology & Urology · 195d

Cleared Dec 14, 2023

Disposable Hot Biopsy Forceps

Gastroenterology & Urology · 184d

Cleared Nov 14, 2022

Disposable hemoclip

Gastroenterology & Urology · 411d

Cleared Jun 06, 2022

Disposable Polypectomy Snare

Gastroenterology & Urology · 250d

Cleared Jun 06, 2022

Multi-Band Ligator

Gastroenterology & Urology · 250d

Cleared Jun 02, 2022

Endoscopic Injection Needle

Gastroenterology & Urology · 245d