Scivita Medical Technology Co., Ltd. is one of 2114 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Scivita Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B), 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
13
Total
13
Cleared
0
Denied
Scivita Medical Technology Co., Ltd. has 13 FDA 510(k) cleared medical devices. Based in Suzhou, CN.
Latest FDA clearance: Aug 2026. Active since 2019.
Browse the FDA 510(k) cleared devices submitted by Scivita Medical Technology Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mid-Link Consulting Co, Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Scivita Medical Technology Co., Ltd.
13 devices
Cleared
Aug 14, 2026
Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
Gastroenterology & Urology
21d
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
Mar 19, 2025
Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B,...
Ear, Nose, Throat
54d
Cleared
Oct 23, 2024
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C,...
Ear, Nose, Throat
265d
Cleared
Oct 15, 2024
Single-use Extraction Baskets
Gastroenterology & Urology
265d
Cleared
Nov 14, 2023
Broncho Videoscope System
Ear, Nose, Throat
172d
Cleared
May 16, 2023
Insufflator
Obstetrics & Gynecology
239d
Cleared
Jan 13, 2023
Scivita 4KINSIGHT ICG Imaging System
General & Plastic Surgery
256d
Cleared
Jul 28, 2021
Broncho Videoscope System
Ear, Nose, Throat
169d
Cleared
Feb 24, 2021
4K UHD Laparoscope
General & Plastic Surgery
112d
Cleared
Aug 21, 2020
4K UHD Camera System
Obstetrics & Gynecology
206d