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Scivita Medical Technology Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD January 20, 2026
K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-March 27, 2025
K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SMarch 19, 2025
K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)October 23, 2024
K240192Single-use Extraction BasketsOctober 15, 2024
K231521Broncho Videoscope SystemNovember 14, 2023
K222812InsufflatorMay 16, 2023
K221252Scivita 4KINSIGHT ICG Imaging SystemJanuary 13, 2023
K210379Broncho Videoscope SystemJuly 28, 2021
K2032554K UHD LaparoscopeFebruary 24, 2021
K2002164K UHD Camera SystemAugust 21, 2020
K1836753D Visualization SystemSeptember 25, 2019