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Scivita Medical Technology Co., Ltd.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories7
Latest FDA decision2026-08-14
TypeNumberDevice NameCodeDateActions
510(k) K262552 Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB2026-08-14 View
510(k) K251338 Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)FBN2026-01-20 View
510(k) K243708 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;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)FGB2025-03-27 View
510(k) K250210 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); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))EOQ2025-03-19 View
510(k) K240289 Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)EOQ2024-10-23 View
510(k) K240192 Single-use Extraction BasketsLQR2024-10-15 View
510(k) K231521 Broncho Videoscope SystemEOQ2023-11-14 View
510(k) K222812 InsufflatorHIF2023-05-16 View
510(k) K221252 Scivita 4KINSIGHT ICG Imaging SystemGCJ2023-01-13 View
510(k) K210379 Broncho Videoscope SystemEOQ2021-07-28 View
510(k) K203255 4K UHD LaparoscopeGCJ2021-02-24 View
510(k) K200216 4K UHD Camera SystemHET2020-08-21 View
510(k) K183675 3D Visualization SystemGCJ2019-09-25 View
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