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Latest 510(k) Clearances
Free preview of the 10 most recent FDA 510(k) decisions.
| 510(k) Number | Applicant | Device Name | Product Code | Decision Date | Decision |
|---|---|---|---|---|---|
| K253581 | Technomed Europe | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | IKT | 2026-03-15 | Substantially Equivalent |
| K253111 | Good Methods Global, Inc. | Aeka Imaging | LLZ | 2026-03-13 | Substantially Equivalent |
| K260499 | Abbott Medical | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | DQY | 2026-03-13 | Substantially Equivalent |
| K253261 | Weero Co., Ltd. | Apollo Quattro (APQ-10M) | PBX | 2026-03-13 | Substantially Equivalent |
| K252249 | Mars Bioimaging , Ltd. | Extremity CT Imaging System | JAK | 2026-03-13 | Substantially Equivalent |
| K260455 | Zeto, Inc. | New Wave System | GWQ | 2026-03-13 | Substantially Equivalent |
| K252923 | Iasis Technologies | IASIS i2 Relaxation Neurofeedback System | 2026-03-13 | Substantially Equivalent | |
| K251916 | Genbody.Inc. | GenBody COVID-19 Ag Home Test | QYT | 2026-03-13 | Substantially Equivalent |
| K260078 | Canon Medical Systems Corporation | Aquilion ServeSP (TSX-307B) V2.0 | JAK | 2026-03-13 | Substantially Equivalent |
| K252648 | Taewoong Medical Co., Ltd. | Niti-S SPAXUS Stent | PCU | 2026-03-13 | Substantially Equivalent |
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