Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007456622

FEI Number

3007456622

Entity Name

NICO CORPORATION

City/State/Country

Indianapolis, IN, US

Establishment Address

250 E 96th St Ste 125, Indianapolis, IN 46240, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRR	Regulator, Temperature	Clinical Chemistry	Class 1	862.2050	2024-10-18
QFX	Diagnostic Neurosurgical Microscope Filter	Neurology	Class 2	882.4950	2024-10-18
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2024-10-18
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2024-10-18
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	Class 2	878.4580	2024-10-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-18
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2024-10-18
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2024-10-18
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1992-12-29
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2024-10-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2024-10-18
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	1996-04-16
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1977-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3015967359	Stryker Instruments	Portage, MI, US
3027645317	INFITEK CO., LTD.	Shanghai, CN
3043088937	SCITEK GLOBAL CO.,LTD	Jinan Shandong, CN
3002889627	BIO-RAD	MARNES-LA-COQUETTE Ile-de-France, FR
3035708936	Bio-Rad Service France SAS	Mitry Mory Ile-de-France, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007456622. Last updated year: 2026. Please use registration number 3007456622 when referencing this establishment in official correspondence.