Canyon Medical, Inc.: FDA clearances and approvals
Canyon Medical, Inc. has 6 FDA 510(k) clearances (first 2023, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time: 154 days. Since 2017 its median was 154 days, against 134 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 193 |
| 2024 | 3 | 94 |
| 2025 | 1 | 242 |
| 2026 | 1 | 269 |
Review time against the same product codes
Since 2017, Canyon Medical, Inc.'s cleared 510(k)s took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 2 | 2 |
| NEY | System, Ablation, Microwave And Accessories | 2 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 | 1 |
Review panels
Most recent Canyon Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254179 | Drainage Catheter | FGE | 2026-09-18 | 269 |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | KRD | 2025-09-23 | 242 |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | NEY | 2024-09-26 | 94 |
| K241825 | Microwave Ablation Antennas | NEY | 2024-09-20 | 88 |
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle | KNW | 2024-01-17 | 114 |
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle | KNW | 2023-04-03 | 193 |
Recalls
openFDA lists no recalls under a recalling firm named Canyon Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Canyon Medical, Inc. have?
Canyon Medical, Inc. has 6 FDA 510(k) clearances (first 2023, latest 2026), across 4 product codes in 3 review panels.
How long does FDA take to clear Canyon Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Canyon Medical, Inc.'s cleared 510(k)s is 154 days. Since 2017: 154 days, versus 134 days for all cleared 510(k)s in the same product codes.
What devices does Canyon Medical, Inc. make?
Its most frequent FDA product codes are KNW (Instrument, Biopsy, 2); NEY (System, Ablation, Microwave And Accessories, 2); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Has Canyon Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Canyon Medical, Inc. Related entities may recall under other names.
Next steps
- See all 6 Canyon Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Canyon Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.