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NICO Corporation

United States·US-MF-000000769

Last updated September 17, 2026

Information

Country: United States
Address: 96th Street, 250 East, Indianapolis, United States
Website: www.niconeuro.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 317 660 7118
PRRC Contact: —
EUDAMED SRN: US-MF-000000769
FDA FEI Number: 3007456622
DUNS Number: 829838288

Catalogue (143)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
NICO Myriad	NN-4007	FDA UDI	Class I	Active
NICO BrainPath Approach	NN-2502	EUDAMED	Class III	Active
NICO BrainPath Approach	NN-2522	EUDAMED	Class III	Active
NICO BrainPath Approach	NN-2503	EUDAMED	Class III	Active
NICO Automated Preservation System	NN-1010	EUDAMEDFDA UDI	Class I	Active
NICO TRIOwand	K150993	FDA 510(k)	Class II	Active
Brain Port	K120691	FDA 510(k)	Class II	Active
Myriad SPECTRA Light Source	K232567	FDA 510(k)	Class II	Active
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook	K150378	FDA 510(k)	Class II	Active
NICO TRIOwand	K162075	FDA 510(k)	Class II	Active
Navigation Probe Adapter	NN-8045	EUDAMEDFDA UDI	Class I	Active
NICO Automated Preservation System	NN-1011	EUDAMEDFDA UDI	Class I	Active
NICO BrainPath Approach	NN-2506	EUDAMED	Class III	Active
NICO BrainPath	NN-8026	EUDAMEDFDA UDI	Class IIa	Active
NICO Myriad	NN-7006	EUDAMEDFDA UDI	Class I	Active
NICO BrainPath Approach	NN-2525	EUDAMED	Class III	Active
NICO BrainPath	NN-8024	EUDAMEDFDA UDI	Class IIa	Active
NICO BrainPath	NN-8042	EUDAMEDFDA UDI	Class IIa	Active
Sterilization Tray, Manipulation Tool	NN-7020	EUDAMED	Class I	Active
NICO Myriad SPECTRA	NN-7048	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-7027	EUDAMED	Class IIb	Active
NICO Myriad SPECTRA	NN-7046	EUDAMED	Class I	Active
NICO Myriad	NN-8022	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-8039	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-7007	EUDAMED	Class I	Active
NICO Myriad	NN-7002	EUDAMEDFDA UDI	Class IIb	Active
NICO Myriad	NN-8014	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-9002	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-8023	EUDAMEDFDA UDI	Class I	Active
Sterilization Tray, Manipulation Tool	NN-9005	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-9004	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-9001	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-7005	EUDAMEDFDA UDI	Class I	Active
NICO BrainPath Approach	NN-2500	EUDAMED	Class III	Active
NICO BrainPath	NN-8025	EUDAMEDFDA UDI	Class IIa	Active
NICO Myriad	NN-9008	EUDAMEDFDA UDI	Class I	Active
NICO Myriad	NN-9006	EUDAMEDFDA UDI	Class I	Active
NICO Myriad NOVUS	NN-7014	EUDAMED	Class IIb	Active
NICO Myriad SPECTRA	NN-7049	EUDAMED	Class IIb	Active
NICO Myriad	NN-7011	EUDAMEDFDA UDI	Class I	Active
Sterilization Tray, Manipulation Tool	NN-7019	EUDAMEDFDA UDI	Class I	Active
NICO BrainPath Approach	NN-2523	EUDAMED	Class III	Active
NICO BrainPath Approach	NN-2501	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

Atlantico Systems, Ltd. IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 30, 2021	Z-1839-2021	—	terminated	(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
Apr 30, 2021	Z-1840-2021	—	terminated	(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
Jun 19, 2018	Z-2822-2018	—	terminated	Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
Jul 29, 2015	Z-2767-2015	—	terminated	Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.
Feb 24, 2014	Z-2045-2016	—	terminated	This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
Jul 17, 2012	Z-2201-2012	—	terminated	BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
Jul 17, 2012	Z-2200-2012	—	terminated	BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.