Myriad SPECTRA Light Source
FDA 510(k) clearance K232567 · decided 2024-03-14
Clearance details
- K-number
- K232567
- Device name
- Myriad SPECTRA Light Source
- Applicant
- Nico Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-08-24
- Decision date
- 2024-03-14
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- QFX
- Device class
- 2
- Regulation number
- 882.4950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product N recall (Z-0600-2026) | Stryker Corporation | 2025-11-26 |