Data / Medical devices / United States / Nico Corporation
Nico Corporation: FDA-registered device maker in Indianapolis, IN, United States, 5 510(k) clearances
Nico Corporation is registered with the FDA (registration 3007456622) in Indianapolis, IN, United States. It lists 17 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 14, 2024. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007456622
- Address
- 250 E 96th St Ste 125, Indianapolis, IN, United States, 46240
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 29, 1977
- Registered through
- 2027
- Brand names listed
- 95 mm Stylet, Aspiration Line Assembly, BLADES, PROBES, BrainPath + Illumination Pack, BrainPath Approach, BrainPath Manipulation Tool, CHISELS, DISSECTORS and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 14, 2024 | K232567 | Myriad SPECTRA Light Source | QFX | Substantially Equivalent | Nico Corporation | accessdata.fda.gov |
| September 13, 2019 | K191599 | NICO Myriad NOVUS | GEI | Substantially Equivalent | Nico Corporation | accessdata.fda.gov |
| September 20, 2018 | K182340 | NICO Myriad | GEI | Substantially Equivalent | Nico Corporation | accessdata.fda.gov |
| September 7, 2017 | K172433 | NICO BrainPath | GZT | Substantially Equivalent | Nico Corporation | accessdata.fda.gov |
| August 11, 2016 | K162075 | NICO TRIOwand | GEI | Substantially Equivalent | Nico Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2021 | 87882 | Class II | Terminated | 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 visualizat | (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, | accessdata.fda.gov |
| June 19, 2018 | 80540 | Class II | Terminated | 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 | accessdata.fda.gov |
| July 29, 2015 | 72015 | Class II | Terminated | 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 handpiec | 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 u | accessdata.fda.gov |
| February 24, 2014 | 74191 | Class II | Terminated | 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 inst | accessdata.fda.gov |
| July 17, 2012 | 62588 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
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- All makers of Illuminator, Fiberoptic, Surgical Field
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- All makers of Light, Surgical, Fiberoptic
Updated March 14, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.