Data / Medical devices / Italy / Spes Medica S.P.A

Spes Medica S.P.A: FDA-registered device maker in Genova Liguria, Italy, 7 510(k) clearances

Name: Spes Medica S.P.A FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spes Medica S.P.A is registered with the FDA (registration 3011534533) in Genova Liguria, Italy. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 10, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011534533
Address: Via Buccari 21, Genova Liguria, Italy, 16153
Owner or operator: Registrar Corp (10088094)
Roles: Exporter to the US, Manufacturer
First device listed: May 24, 2023
Registered through: 2026
Brand names listed: Gold Cup Electrode, Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode

Devices it lists

Device	Product code	Class	Role	Source
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	FAP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Degreaser, Skin, Surgical	KOY	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Electrode, Cortical	GYC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Exporter to the US, Manufacturer	accessdata.fda.gov

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
November 10, 2022	K211954	Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid	GYC	Substantially Equivalent	Spes Medica Srl	accessdata.fda.gov
December 1, 2021	K212326	AC Cream - Conductive paste	GYB	Substantially Equivalent	Spes Medica Srl	accessdata.fda.gov
January 17, 2020	K192606	SAC2 - Electrode Cream	GYB	Substantially Equivalent	Spes Medica Srl	accessdata.fda.gov
December 21, 2017	K171102	Ives MR Conditional Cup Electrode	GXY	Substantially Equivalent	Ives Egg Solutions	accessdata.fda.gov
December 13, 2012	K113771	SIGNAL GEAR URETHRAL CATHETER ELECTRODE	FAP	Substantially Equivalent	Neurovision Medical Products, Inc.	accessdata.fda.gov
August 24, 2010	K093373	LARYNGEAL SURFACE ELECTRODE	ETN	Substantially Equivalent	Spes Medica Srl	accessdata.fda.gov
September 7, 2007	K071118	GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE	GXY	Substantially Equivalent	Ives Eeg Solutions, Inc.	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 8, 2021	87999	Class II	Terminated	Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.	The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.	accessdata.fda.gov

Compare with other makers

Updated November 10, 2022. 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.