NICO BrainPath Approach

EUDAMEDFDA 510(k)

Class III (EU MDR)

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Identity

Trade Name: NICO BrainPath Approach EUDAMED
Device Name: NICO BrainPath Approach EUDAMED
Model / Reference: NN-2501 EUDAMED
NN-2505 EUDAMED
NN-2504 EUDAMED
NN-2521 EUDAMED
NN-2526 EUDAMED
NN-2527 EUDAMED
NN-2524 EUDAMED

Primary DI / UDI-DI: 00816744022518 EUDAMED
00816744022556 EUDAMED
00816744022549 EUDAMED
00816744022716 EUDAMED
00816744022761 EUDAMED
00816744022778 EUDAMED
00816744022747 EUDAMED
Basic UDI-DI: 081674402PP1FG EUDAMED
EMDN Code: Z12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED

Device Class: Class III EUDAMED
Medical Purpose: To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as Primary/Secondary brain tumors, Vascular abnormalities/malformations, Intraventricular tumors/cysts EUDAMED

Sterile

Yes

EUDAMED

NICO BrainPath Approach by NICO Corporation — Class III — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K172433	Class III	Active
EUDAMED	European Union	CE/MDR	081674402PP1FG	Class III	Active

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