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SPINERY Needle

FDA UDI

Class II (US FDA UDI)

by Axon Srl

Identity

Trade Name
SPINERY Needle FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar FDA UDI
Device Name
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. FDA UDI
Model / Reference
SP-BI0704 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860011603603 FDA UDI
510(k) Number
K223303 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar

SPINERY Needle by Axon Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar.

Cleared under the same submission

K223303 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Axon Srl

Sources (1)

  • FDA UDI 799c80be-14b4-48f4-a17f-f972ba7cd944 34 fields · synced May 30, 2026