FDA 510(k) Applications for Medical Device Product Code "FAN"
(Sigmoidoscope, Rigid, Electrical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K232262 | SurgEase Innovations Limited | LumenEye« X1 endoscope (LX1-SCP-203); LumenEye« X1 consumables (LX1-CSB-201); LumenEye« X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | 11/30/2023 |
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