AXON SRL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30306450163030645016AXON SRL1N2026-01-01Via Lepanto 84 Pompei Napoli IT 80045

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3270961985672242K223303Spinery™ RF Ablation SystemGEI2023-08-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI12023-08-30

GUDID#

SPINERY Needle - Spinery (RF) Needles are composed by a handle with electrode cooled needle and are offered in bipolar configurations. The available variants consist of cooled needles capable of providing irrigation of tissue through needle tip during ablation procedure. The needle is hollow and its inner space is divided into 3 concentric lumens: • the inner central lumen is used to distally deliver the irrigation solution to the tip of the RF needle; a hole on the needle tip allows the irrigation solution to reach tissues (the irrigation solution could be also delivered proximally through the insulation and irrigation cannula); • the intermediate lumen is used to deliver a cooling fluid through the proximal SpineryTM RF Ablation System by Axon Spine Medical Systems thermocouple; • the outer external lumen returns the cooling fluid from the proximal thermocouple towards the cooling tubing circuit connected to the handle of the RF needle device; the cooling fluid is not intended to come in contact with patient tissue because it flows in a closed circuit. The needles also contain two thermocouples, a distal thermocouple inside the ablation area and proximal thermocouple at the edge of ablation area that permit real-time monitoring of temperatures at the center of the ablation zone and at the edge of ablation area ensuring that no healthy tissue around tumor is damaged.

AXON SRL

2024-05-31

SPINERY Needle - Spinery (RF) Needles are composed by a handle with electrode cooled needle and are offered in bipolar configurations. The available variants consist of cooled needles capable of providing irrigation of tissue through needle tip during ablation procedure. The needle is hollow and its inner space is divided into 3 concentric lumens: • the inner central lumen is used to distally deliver the irrigation solution to the tip of the RF needle; a hole on the needle tip allows the irrigation solution to reach tissues (the irrigation solution could be also delivered proximally through the insulation and irrigation cannula); • the intermediate lumen is used to deliver a cooling fluid through the proximal SpineryTM RF Ablation System by Axon Spine Medical Systems thermocouple; • the outer external lumen returns the cooling fluid from the proximal thermocouple towards the cooling tubing circuit connected to the handle of the RF needle device; the cooling fluid is not intended to come in contact with patient tissue because it flows in a closed circuit. The needles also contain two thermocouples, a distal thermocouple inside the ablation area and proximal thermocouple at the edge of ablation area that permit real-time monitoring of temperatures at the center of the ablation zone and at the edge of ablation area ensuring that no healthy tissue around tumor is damaged.

AXON SRL

2024-05-27

SPINERY Generator - SPINERY Generator (REF: SPINERY) is a RadioFrequency Generator used for parameter control and treatment modulation; equipped with a peristaltic pump intended to allow the flow of a close cooling fluid (sterile saline water) inside RF electrode needles during ablation procedure. A Footswitch, used to control the activation and interruption of the ablation, is provided together with the Generator. A Stainless-Steel rod is also provided to hang up the sterile water bag for used for cooling system circuit.

AXON SRL

2024-05-27