Scivita Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: 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, Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P)
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scivita Medical Technology Co., Ltd. Gastroenterology & Urology ✕
3 devices
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