Canyon Medical Inc.
Manufacturer and brand owner in Nanjing, Jiangsu, China. 4 device types, 9 products catalogued, 5 clearances.
Canyon Medical Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Instrument, Biopsy, Device, Percutaneous, Biopsy and 2 other device types. 9 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
4device types registered with the FDA
9products catalogued under its own name
5510(k) clearances
Registration
| Registered name | CANYON MEDICAL INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016688836 |
| FEI number | 3016688836 |
| DUNS | 527310648 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 南京康友医疗科技有限公司 |
|---|---|
| Unified social credit code | 91320113134962555F |
| Source | NMPA UDI database |
Location
| City | Nanjing |
|---|---|
| Province | Jiangsu |
| Address | Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue, Jiangbei New Area, 210032, Nanjing, Jiangsu Province |
| Postal code | 210032 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Percutaneous, Biopsy | Class 1 | Fine Needle Aspiration Biopsy Needle | 2025 | 5 |
| Device, Vascular, For Promoting Embolization | Class 2 | Polyvinyl Alcohol Embolic Microspheres | 2025 | 6 |
| Instrument, Biopsy | Class 2 | M Biopsy Semi-automatic Disposable Biopsy Needle, M Biopsy Coaxial Biopsy Needle, M Biopsy Automatic Disposable Biopsy Needle, SureCore Automatic Disposable Biopsy Needle, SureCore Semi-automatic Disposable Biopsy Needle, SureAim Coaxial Biopsy Needle | 2023 | 9 |
| System, Ablation, Microwave And Accessories | Class 2 | Microwave Ablation Antennas, Microwave Ablation Generator | 2024 | 10 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| SureAim Coaxial Biopsy Needle | KNW | 157 |
| SureCore Automatic Disposable Biopsy Needle | KNW | 156 |
| M Biopsy Automatic Disposable Biopsy Needle | KNW | 108 |
| M Biopsy Coaxial Biopsy Needle | KNW | 89 |
| SureCore Semi-automatic Disposable Biopsy Needle | KNW | 76 |
| Microwave Ablation Antennas | NEY | 66 |
| M Biopsy Semi-Automatic Disposable Biopsy Needle | KNW | 52 |
| Polyvinyl Alcohol Embolic Microspheres | KRD | 36 |
| Microwave Ablation Generator | NEY | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250209 | 2025-09-23 | KRD | Traditional | This company |
| K241827 | 2024-09-26 | NEY | Traditional | This company |
| K241825 | 2024-09-20 | NEY | Traditional | This company |
| K233031 | 2024-01-17 | KNW | Traditional | This company |
| K222865 | 2023-04-03 | KNW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1986 |
|---|---|
| Factory area | 8549 m² (including 1363 m² Class 10000 cleanroom) |
| Main products | Microwave ablation systems, RF ablation systems, Percutaneous intervention devices, Transbronchial intervention devices, Transvascular intervention devices |
| Certifications | National High-tech Enterprise, NMPA Registration, Jiangsu Postdoctoral Innovation Practice Base |
| Export markets | 40+ countries and regions worldwide |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.