NavaClick Injection System
FDA 510(k) clearance K231877 · decided 2023-11-30
Clearance details
- K-number
- K231877
- Device name
- NavaClick Injection System
- Applicant
- Lineage Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-26
- Decision date
- 2023-11-30
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Stuart, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NavaClick Syringe and Needle, Model Number LIN02 recall (Z-2535-2024) | LINEAGE BIOMEDICAL, INC | 2024-08-08 |