Nico Corporation
Indianapolis, IN, US
NICO CORPORATION appears in FDA device records in Indianapolis, IN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Nico Corporation between 2012 and 2024. The busiest year on record is 2015, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232567 | Myriad SPECTRA Light Source | QFX | Substantially Equivalent | |
| K191599 | NICO Myriad NOVUS | GEI | Substantially Equivalent | |
| K182340 | NICO Myriad | GEI | Substantially Equivalent | |
| K172433 | NICO BrainPath | GZT | Substantially Equivalent | |
| K161307 | NICO Myriad | GEI | Substantially Equivalent | |
| K162075 | NICO TRIOwand | GEI | Substantially Equivalent | |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | GZT | Substantially Equivalent | |
| K150993 | NICO TRIOwand | GEI | Substantially Equivalent | |
| K120691 | BRAIN PORT | GZT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007456622 | 3007456622 | NICO CORPORATION | 250 E 96th St Ste 125, Indianapolis, IN 46240 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FMHContainer, Specimen, Sterile
- QFXDiagnostic Neurosurgical Microscope Filter
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- GDGHook, Surgical, General & Plastic Surgery
- HBIIlluminator, Fiberoptic, Surgical Field
- MDMInstrument, Manual, Surgical, General Use
- HAOInstrument, Surgical, Non-Powered
- FSTLight, Surgical, Fiberoptic
- HBCMotor, Drill, Electric
- OJGNeurological Tray
- JRRRegulator, Temperature
- GZTRetractor, Self-Retaining, For Neurosurgery
- GAHStylet, Surgical, General & Plastic Surgery
- KYZSyringe, Irrigating (Non Dental)
- BYYTube, Aspirating, Flexible, Connecting
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1840-2021 | Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietary connector to ensure usage is reserved for the Myriad-LX Illumination Fiber. | (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. | Class II | Terminated | |
| Z-1839-2021 | NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System. | (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. | Class II | Terminated | |
| Z-2822-2018 | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024 | 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 | Class II | Terminated | |
| Z-2767-2015 | NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited. | 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. | Class II | Terminated | |
| Z-2045-2016 | Myriad handpiece Tissue morcellator | 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. | Class II | Terminated | |
| Z-2201-2012 | 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. | 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. | Class II | Terminated | |
| Z-2200-2012 | 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain