Data / Medical devices / China / Canyon Medical Inc.

Canyon Medical Inc.: FDA-registered device maker in Nanjing Jiangsu, China, 6 510(k) clearances

Name: Canyon Medical Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Canyon Medical Inc. is registered with the FDA (registration 3016688836) in Nanjing Jiangsu, China. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 18, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3016688836
Address: Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue, Jiangbei New Area, 210032, Nanjing, Jiangsu Province People's Republic of China, Nanjing Jiangsu, China, 210032
Owner or operator: Canyon Medical Inc. (10064500)
Roles: Manufacturer
First device listed: May 18, 2023
Registered through: 2026
Brand names listed: Drainage Catheter, Fine Needle Aspiration Biopsy Needle, M Biopsy Automatic Disposable Biopsy Needle, M Biopsy Coaxial Biopsy Needle, M Biopsy Semi-automatic Disposable Biopsy Needle, Microwave Ablation Antennas, Microwave Ablation Generator, Polyvinyl Alcohol Embolic Microspheres and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Manufacturer	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Manufacturer	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer	accessdata.fda.gov
System, Ablation, Microwave And Accessories	NEY	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 18, 2026	K254179	Drainage Catheter	FGE	Substantially Equivalent	Canyon Medical, Inc.	accessdata.fda.gov
September 23, 2025	K250209	Polyvinyl Alcohol Embolic Microspheres	KRD	Substantially Equivalent	Canyon Medical, Inc.	accessdata.fda.gov
September 26, 2024	K241827	Microwave Ablation Generator (KY-2000A, KY-2100A)	NEY	Substantially Equivalent	Canyon Medical, Inc.	accessdata.fda.gov
September 20, 2024	K241825	Microwave Ablation Antennas	NEY	Substantially Equivalent	Canyon Medical, Inc.	accessdata.fda.gov
January 17, 2024	K233031	M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle	KNW	Substantially Equivalent	Canyon Medical, Inc.	accessdata.fda.gov
April 3, 2023	K222865	M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle	KNW	Substantially Equivalent	Canyon Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 18, 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.