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Data / Medical devices / China / Scivita Medical Technology Co., Ltd.

Scivita Medical Technology Co., Ltd.: FDA-registered device maker in suzhou Jiangsu, China, 12 510(k) clearances

Scivita Medical Technology Co., Ltd. is registered with the FDA (registration 3020746799) in suzhou Jiangsu, China. It lists 19 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 14, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Scivita Medical Technology Co., Ltd.
FDA registration number
3020746799
Address
No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA, suzhou Jiangsu, China, 215000
Owner or operator
SCIVITA MEDICAL TECHNOLOGY CO., LTD. (10082577)
Roles
Manufacturer
First device listed
August 17, 2021
Registered through
2026
Brand names listed
3D Visualization System, 4K UHD Camera System, 4K UHD Laparoscope, Brocho Videoscope System, Broncho Videoscope System, Bronchus Sampler, Endoscopic Image Processor, Full HD Enodscopic Image Processor and more

Devices it lists

DeviceProduct codeClassRoleSource
ArthroscopeHRX2Manufactureraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufactureraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Manufactureraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Manufactureraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Manufactureraccessdata.fda.gov
Endoscope, Accessories, Narrow Band SpectrumNWB2Manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufactureraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Manufactureraccessdata.fda.gov
Laparoscope And Accessories, Gynecologic, ReprocessedNMH2Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufactureraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Manufactureraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 14, 2026K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGBSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
March 27, 2025K243708Urology 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.)FGBSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
March 19, 2025K250210Broncho 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))EOQSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
October 23, 2024K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)EOQSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
October 15, 2024K240192Single-use Extraction BasketsLQRSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
November 14, 2023K231521Broncho Videoscope SystemEOQSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
May 16, 2023K222812InsufflatorHIFSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
January 13, 2023K221252Scivita 4KINSIGHT ICG Imaging SystemGCJSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
July 28, 2021K210379Broncho Videoscope SystemEOQSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
February 24, 2021K2032554K UHD LaparoscopeGCJSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
August 21, 2020K2002164K UHD Camera SystemHETSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov
September 25, 2019K1836753D Visualization SystemGCJSubstantially EquivalentScivita Medical Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.