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Data / Medical devices / China / Jiangsu Vedkang Medical Science and Technology Co.,Ltd.

Jiangsu Vedkang Medical Science and Technology Co.,Ltd.: FDA-registered device maker in Changzhou Jiangsu, China, 7 510(k) clearances

Jiangsu Vedkang Medical Science and Technology Co.,Ltd. is registered with the FDA (registration 3013526170) in Changzhou Jiangsu, China. It lists 20 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 29, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3013526170
Address
No. 2-1, Changyang Road, Wujin Economic Development Zone, Changzhou Jiangsu, China, 213145
Owner or operator
Jiangsu Vedkang Medical Science and Technology Co.,Ltd (10053440)
Roles
Manufacturer
First device listed
December 6, 2016
Registered through
2027
Brand names listed
3-Stage Balloon Dilation Catheter, Balloon Inflators, Bougie Dilator, Dilation Balloons, Disposable Bite Block, Disposable Cleaning Brush, Disposable Cold Snares; Disposable Grasping Forceps with Net, Disposable Endoscopic Hemoclip and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Manufactureraccessdata.fda.gov
Adaptor, CatheterGCE1Manufactureraccessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGCA2Manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Manufactureraccessdata.fda.gov
Bougie, Esophageal, And Gastrointestinal, Gastro-UrologyFAT2Manufactureraccessdata.fda.gov
Dilator, EsophagealKNQ2Manufactureraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Manufactureraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Manufactureraccessdata.fda.gov
Endoscopic Bite BlockMNK1Manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, ExemptPTS2Manufactureraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufactureraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufactureraccessdata.fda.gov
Hemostatic Metal Clip For The Gi TractPKL2Manufactureraccessdata.fda.gov
Snare, FlexibleFDI2Manufactureraccessdata.fda.gov
Snare, Non-ElectricalFGX1Manufactureraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Manufactureraccessdata.fda.gov
Syringe, Balloon Inflation, ExemptPTM2Manufactureraccessdata.fda.gov
Trap, Sterile SpecimenBYZ2Manufactureraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Manufactureraccessdata.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
March 29, 2024K232825Disposable SphincterotomeKNSSubstantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.accessdata.fda.gov
February 26, 2024K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)GCASubstantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.accessdata.fda.gov
February 15, 2024K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)FGESubstantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.accessdata.fda.gov
September 12, 2023K230598Stone Extraction BasketsLQRSubstantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.accessdata.fda.gov
March 28, 2023K222146Disposable Endoscopic HemoclipPKLSubstantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.accessdata.fda.gov
September 22, 2022K220089Disposable Polyp SnareFDISubstantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.accessdata.fda.gov
July 29, 2022K213914Injection NeedleFBKSubstantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated March 29, 2024. 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.