Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611854

FEI Number

3002807258

Entity Name

IGEA SPA

City/State/Country

Carpi (MO) Modena, IT

Establishment Address

Via Parmenide, 10/A, Carpi (MO) Modena 41012, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IGEA S.p.A. (Owner Number: 10025254)

Owner / Operator Contact Address

Via Parmenide, 10/A, Carpi (MO), IT-MO 41012, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NanoKnife Generator (H78720300301 USO); NanoKnife 3.5 Generator (P/N H78720300351US0) NanoKnife 3 Generator NanoKnife Generator Onocbionic System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2025-01-16
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2026-06-15
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2019-06-28
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2015-06-26
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2008-03-27
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2008-03-27

Official Correspondent

Chiara Guerrieri

US Agent Details

Amira Milutinovic Business: ORTHOFIX LLC Email: AmiraMilutinovic@Orthofix.com Phone: (214) 9372196

Related Public Records

Same Entity

IGEA S.p.A.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K120857	Ncontact Surgical, Inc.	EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX	2012-11-13

Similar Registrations

Registration Number	Establishment Name	Location
3015540957	SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.	Cixi Zhejiang, CN
2244478	LYNX Medical NJ	Franklin, NJ, US
1319639	Sterigenics U.S., LLC	Queensbury, NY, US
1000523114	AngioDynamics, Inc.	Marlborough, MA, US
3017892510	ANGIODYNAMICS, INC	Glens Falls, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611854. Last updated year: 2026. Please use registration number 9611854 when referencing this establishment in official correspondence.