Medical Device Manufacturer · CN , Suzhou

Scivita Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2019

Recent clearances: Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B), Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G, Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P

13

Total

13

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Aug 14, 2026

Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)

Gastroenterology & Urology · 21d

Cleared Jan 20, 2026

Cholangioscope Visualization System (Single-use Video Cholangioscope:...

Gastroenterology & Urology · 265d

Cleared Mar 27, 2025

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B,...

Gastroenterology & Urology · 115d

Cleared Oct 15, 2024

Single-use Extraction Baskets

Gastroenterology & Urology · 265d