Chrysalis Intelligence · Sponsors · Scivita Medical Technology Co., Ltd.

Scivita Medical Technology Co., Ltd.

Suzhou, CN · 12 510(k) clearances

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Total clearances
12
2020-08-21 → 2026-08-14
Last 12 months
2
Product codes
7
Most recent
2026-08-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EOQ Bronchoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 4 2025-03-19
FGB — — — 2 2026-08-14
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 2 2023-01-13
FBN Choledochoscope And Accessories, Flexible/Rigid Class II Gastroenterology, Urology 1 2026-01-20
LQR Dislodger, Stone, Biliary Class II Gastroenterology, Urology 1 2024-10-15
HIF Insufflator, Laparoscopic Class II Obstetrics/Gynecology 1 2023-05-16
HET Laparoscope, Gynecologic (And Accessories) Class II Obstetrics/Gynecology 1 2020-08-21
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2026-08-14 K262552 Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) FGB — —
2026-01-20 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 Class II Gastroenterology, Urology
2025-03-27 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 — —
2025-03-19 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 Class II Ear, Nose, Throat
2024-10-23 K240289 Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) EOQ Class II Ear, Nose, Throat
2024-10-15 K240192 Single-use Extraction Baskets LQR Class II Gastroenterology, Urology
2023-11-14 K231521 Broncho Videoscope System EOQ Class II Ear, Nose, Throat
2023-05-16 K222812 Insufflator HIF Class II Obstetrics/Gynecology
2023-01-13 K221252 Scivita 4KINSIGHT ICG Imaging System GCJ Class II Gastroenterology, Urology
2021-07-28 K210379 Broncho Videoscope System EOQ Class II Ear, Nose, Throat
2021-02-24 K203255 4K UHD Laparoscope GCJ Class II Gastroenterology, Urology
2020-08-21 K200216 4K UHD Camera System HET Class II Obstetrics/Gynecology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence