Device details
FDA 510(k) registration fields
- K number
- K252745
- Device name
- Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
- Country / region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-08-29
- Decision date
- 2025-12-12
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatmentOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
