Company ยท US
Okami Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 6, 2026 | K262798 | LOBO Vascular Occlusion System Okami Medical, Inc. | KRD |
| Apr 10, 2026 | K260508 | LOBO Vascular Occlusion System Okami Medical, Inc. | KRD |
| Dec 20, 2024 | K242644 | SENDERO MAX Delivery Catheter Okami Medical, Inc. | DQY |
| Mar 8, 2024 | K240384 | SENDERO Microcatheter Okami Medical, Inc. | DQY |
| Nov 17, 2023 | K231600 | SENDERO Microcatheter Okami Medical, Inc. | DQY |
| Apr 29, 2022 | K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) Okami Medical | KRD |
| Nov 5, 2020 | K203025 | LOBO Vascular Occlusion System (model LOBO-5) Okami Medical | KRD |
| Oct 30, 2019 | K192083 | Okami Medical LOBO Vascular Occlusion System Okami Medical | KRD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||