NICO Myriad NOVUS
FDA 510(k) clearance K191599 · decided 2019-09-13
Clearance details
- K-number
- K191599
- Device name
- NICO Myriad NOVUS
- Applicant
- Nico Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-06-17
- Decision date
- 2019-09-13
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; recall (Z-0599-2026) | Stryker Corporation | 2025-11-26 |
| NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product N recall (Z-0600-2026) | Stryker Corporation | 2025-11-26 |
| NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; recall (Z-0601-2026) | Stryker Corporation | 2025-11-26 |