Surgify Halo - Surgify Halo (54.140.SHD.H1)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251433

Identifiers

510(k) Number: K251433 FDA 510(k)
FDA Product Code: HBE FDA 510(k)
Models / Variants: Surgify Halo (54.085.SHD.H1) FDA 510(k)
Surgify Halo (54.140.SHD.H1) FDA 510(k)
Surgify Halo (54.070.NVG.H1) FDA 510(k)
Surgify Halo (54.125.NVG.H1) FDA 510(k)
Surgify Halo (54.000.SEE.H1) FDA 510(k)
Surgify Halo (40.070.NVG.H1) FDA 510(k)
Surgify Halo (40.125.NVG.H1) FDA 510(k)
Surgify Halo (40.000.SEE.H1) 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 - Surgify Halo (54.140.SHD.H1) by Surgify Medical Oy — Class II — FDA_510K — listed in FDA 510(k) — 8 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	K251433	Class II	Active

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Manufacturer

Manufacturer: Surgify Medical Oy

Sources (1)

FDA 510(k) K251433 24 fields · synced Jun 18, 2026