FDA Registration
Active
🇺🇸 United States
NICO CORPORATION
Reg #: 3007456622
·
FEI: 3007456622
·
Expires 2026
Products
17
Proprietary Names
38
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- NICO CORPORATION
- Registration Number
- 3007456622
- FEI Number
- 3007456622
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 250 E 96th St Ste 125
- City
- Indianapolis
- State
- IN
- ZIP
- 46240
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232567
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Regulator, Temperature | JRR | Class 1 | Clinical Chemistry | No | 2024-10-18 |
| Diagnostic Neurosurgical Microscope Filter | QFX | Class 2 | Neurology | No | 2024-10-18 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2024-10-18 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2024-10-18 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 2024-10-18 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-10-18 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2024-10-18 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2024-10-18 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1992-12-29 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2024-10-18 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2024-10-18 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 1996-04-16 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 1977-12-29 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2007-01-04 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2024-10-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2005-04-26 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2024-10-21 |
Proprietary Names
NICO Specimen Preserver
Myriad SPECTRA LightSource
Myriad Illumination Pack
Specimen Collector with Filter Element
NICO Myriad NOVUS: Myriad-LX
NICO Myriad NOVUS Handpiece
NICO Myriad NOVUS Console
NICO Myriad NOVUS: Illumination Pack
NICO SecureHold
Nico Shepherd's Hook
NICO Brainpath Obturator
NICO BrainPath Sheath
NICO TRIOwand
Specimen Infusion Valve
NICO Fluid System
95 mm Stylet
NICO Myriad Handpiece
NICO Myriad Console
SURGICAL KNIVES
OSTEOTOMES
DISSECTORS
FASCIA CUTTER
BLADES, PROBES
CHISELS
FORCEPS
meniGLIDE
Aspiration Line Assembly
LITe BIO Delivery System - Loading Tool
LITe BIO Delivery System - Loading Funnel
MANUAL SURGICAL INSTRUMENTS
WIRE CADDY
General Instruments
PRECISION DOWEL BONE GRAFT SYSTEM
Instruments for Coverloc Volar Plat
BrainPath Manipulation Tool
BrainPath Approach
Myriad Handpiece + Illumination Pack
BrainPath + Illumination Pack
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198