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Shenzhen Wisonic Medical Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 6 510(k) clearances

Name: Shenzhen Wisonic Medical Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Wisonic Medical Technology Co., Ltd. is registered with the FDA (registration 3014302721) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 15, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3014302721
Address: Building 9, Baiwang Creative Factory, No. 1051, Songbai Road, Xili Street, Nanshan District, 518055 Shenzhen, Shenzhen Guangdong, China, 518055
Owner or operator: Shenzhen Wisonic Medical Technology Co., Ltd. (10056768)
Roles: Exporter to the US, Manufacturer
First device listed: January 14, 2018
Registered through: 2026
Brand names listed: Biopsy Needle Guide Kit; Disposable Needle Guides; Reusable Needle Guides, Labat series Diagnostic Ultrasound System

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle Guide Kit	OIJ	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 15, 2023	K230066	Carnation series Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Wisonic Medical Technology Co. , Ltd.	accessdata.fda.gov
December 2, 2021	K211886	Clivia series Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Wisonic Medical Technology Co. , Ltd.	accessdata.fda.gov
July 30, 2021	K210154	Labat series Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Wisonic Medical Technology Co. , Ltd.	accessdata.fda.gov
November 20, 2018	K182715	Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Wisonic Medical Technology Co. , Ltd.	accessdata.fda.gov
May 9, 2018	K180461	Navi e/Navi s/Navi X Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Wisonic Medical Technology Co. , Ltd.	accessdata.fda.gov
January 2, 2018	K163712	Clover 50/Clover60/Clover70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Wisonic Medical Technology Co. , Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 15, 2023. 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.