FDA.reportPublic FDA data

RF THERMOCOUPLE ELECTRODE

Primary DI
05060224333990
Brand
RF THERMOCOUPLE ELECTRODE
Company
ITALIAN ENGINEERING SRL
Model
RFEL-R100-IE
Device description
The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505).
Published
2023-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220505000ATTIVAItalian Engineering S.R.L.2023-02-09GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060224333990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060224333990050602243339905060224333990

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe, denervation, monopolar, reusableA semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length100Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431954955
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055510890131RF BLUNT STRAIGHT CANNULA, 22Gx100mm, ACTIVE TIP 10mm (w holder)RF0M22100R10A2023-08-04
08058341213919RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder)RF0MXXYYYRZZA2023-03-28
08058341218716RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w/o Holder)RF0MXXYYYRZZ2023-03-28
05060224333983RF THERMOCOUPLE ELECTRODERFEL-R50-IE2023-03-28
05060224334003RF THERMOCOUPLE ELECTRODERFEL-R150-IE2023-03-28
05060224334010RF THERMOCOUPLE ELECTRODERFEL-R200-IE2023-03-28
05060224334072INTERMEDIATE CABLECBEL-R-IE2023-03-20
08055510890087ATTIVAMD012023-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
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08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
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08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16