← Back to catalogue
Surgify Halo (54.085.SHD.U1) +10 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K253627
Identifiers
- 510(k) Number
- K253627 FDA 510(k)
- FDA Product Code
- HBE FDA 510(k)
- Models / Variants
- Surgify Halo (54.085.SHD.U1) FDA 510(k)Surgify Halo (54.140.SHD. U1) FDA 510(k)Surgify Halo (54.070.NVG.U1) FDA 510(k)Surgify Halo (54.125.NVG.U1) FDA 510(k)Surgify Halo (54.000.SEE.U1) FDA 510(k)Surgify Halo (40.070.NVG.U1) FDA 510(k)Surgify Halo (40.125.NVG.U1) FDA 510(k)Surgify Halo (40.000.SEE.U1) FDA 510(k)Surgify Halo (30.070.NVG.U2) FDA 510(k)Surgify Halo (30.125.NVG.U2) FDA 510(k)Surgify Halo (30.000.SEE.U2) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4310 FDA 510(k)
- Regulation Number
- 882.4310 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Surgify Halo (54.085.SHD.U1) +10 more models by Surgify Medical Oy — Class II — FDA_510K — listed in FDA 510(k) — 11 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253627 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgify Medical Oy
Sources (1)
- FDA 510(k) K253627 24 fields · synced Jun 18, 2026