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Scivita Medical Technology Co., Ltd.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories7
Latest Approval2026-01-20
TypeNumberDevice NameCodeDate
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) FBN 2026-01-20 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.) FGB 2025-03-27 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)) EOQ 2025-03-19 View
510(k) K240289 Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) EOQ 2024-10-23 View
510(k) K240192 Single-use Extraction Baskets LQR 2024-10-15 View
510(k) K231521 Broncho Videoscope System EOQ 2023-11-14 View
510(k) K222812 Insufflator HIF 2023-05-16 View
510(k) K221252 Scivita 4KINSIGHT ICG Imaging System GCJ 2023-01-13 View
510(k) K210379 Broncho Videoscope System EOQ 2021-07-28 View
510(k) K203255 4K UHD Laparoscope GCJ 2021-02-24 View
510(k) K200216 4K UHD Camera System HET 2020-08-21 View
510(k) K183675 3D Visualization System GCJ 2019-09-25 View
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