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Sign in to claim this brandNICO 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
- —
- —
- [email protected]
- Phone
- +1 317 660 7118
- PRRC Contact
- —
- EUDAMED SRN
- US-MF-000000769
- FDA FEI Number
- 3007456622
- DUNS Number
- 829838288
Catalogue (143)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NICO BrainPath Approach | NN-3009 | FDA UDI | Class I | Active |
| NICO Myriad | NN-7030 | FDA UDI | Class II | Unknown |
| NICO Myriad | NN-8000 | FDA UDI | Class II | Active |
| NICO BrainPath Approach | NN-2021 | FDA UDI | Class I | Active |
| NICO Myriad | NN-8002 | FDA UDI | Class II | Active |
| NICO Myriad | NN-8006 | FDA UDI | Class II | Active |
| NICO Myriad SPECTRA | NN-7047 | FDA UDI | Class II | Active |
| NICO Myriad | NN-8001 | FDA UDI | Class II | Active |
| NICO SecureHold | NN-8041 | FDA UDI | Class I | Active |
| NICO BrainPath Approach | NN-2024 | FDA UDI | Class I | Active |
| NICO Myriad | NN-1310 | FDA UDI | Class II | Active |
| NICO Myriad NOVUS | NN-7012 | FDA UDI | Class II | Active |
| NICO BrainPath | NN-7028 | FDA UDI | Class II | Unknown |
| NICO BrainPath Approach | NN-2025 | FDA UDI | Class I | Active |
| NICO Myriad | NN-1113 | FDA UDI | Class II | Active |
| NICO Myriad | NN-8018 | FDA UDI | Class II | Active |
| NICO Myriad | NN-8016 | FDA UDI | Class I | Active |
| NICO BrainPath Approach | NN-2004 | FDA UDI | Class I | Active |
| NICO BrainPath Approach | NN-2000 | FDA UDI | Class I | Active |
| NICO Myriad-LX | NN-7064 | FDA UDI | Class II | Active |
| NICO BrainPath | NN-7017 | FDA UDI | Class II | Active |
| NICO BrainPath Approach | NN-2023 | FDA UDI | Class I | Active |
| NICO BrainPath Approach | NN-3003 | FDA UDI | Class I | Active |
| NICO Myriad | NN-8021 | FDA UDI | Class II | Active |
| NICO BrainPath | NN-7018 | FDA UDI | Class II | Unknown |
| NICO Myriad NOVUS | NN-7060 | FDA UDI | Class II | Active |
| NICO Myriad | NN-1313 | FDA UDI | Class II | Active |
| NICO Myriad | NN-7000L | FDA UDI | Class II | Active |
| NICO BrainPath Approach | NN-2027 | FDA UDI | Class I | Active |
| NICO Myriad | NN-4006 | FDA UDI | Class I | Active |
| NICO BrainPath Approach | NN-3010 | FDA UDI | Class I | Active |
| NICO BrainPath Approach | NN-2026 | FDA UDI | Class I | Active |
| NICO Myriad | NN-1001 | FDA UDI | Class II | Active |
| NICO BrainPath | NN-7036 | FDA UDI | Class II | Active |
| NICO Myriad | NN-1000 | FDA UDI | Class II | Active |
| NICO Myriad | NN-7000 | FDA UDI | Class II | Active |
| NICO Myriad | NN-8010 | FDA UDI | Class II | Active |
| NICO Myriad-LX | NN-1000 | FDA UDI | Class I | Active |
| NICO BrainPath | NN-7032 | FDA UDI | Class II | Unknown |
| NICO Myriad | NN-8007 | FDA UDI | Class II | Active |
| NICO BrainPath Approach | NN-3005 | FDA UDI | Class I | Active |
| NICO BrainPath Approach | NN-3002 | FDA UDI | Class I | Active |
| NICO BrainPath | NN-7040 | FDA UDI | Class II | Active |
| NICO BrainPath | NN-7038 | FDA UDI | Class II | Active |
| NICO Myriad-LX | NN-7013 | FDA UDI | Class II | Unknown |
| NICO Myriad | NN-7002L | FDA UDI | Class II | Active |
| NICO BrainPath | NN-8030 | FDA UDI | Class II | Active |
| NICO Myriad-LX | NN-9010 | FDA UDI | Class II | Active |
| NICO BrainPath | NN-8011 | FDA UDI | Class II | Active |
| NICO BrainPath Approach | NN-3007 | FDA UDI | Class I | Active |
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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. |