FDA.reportPublic FDA data

Radiofrequency (RF) Needle

Primary DI
M661SST221505
Brand
Radiofrequency (RF) Needle
Company
Spectra Medical Devices, LLC
Model
SST221505SL
Device description
22G x 15cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black Cap
Published
2024-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXIProbe, Radiofrequency Lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032196000NBD DISPOSABLE RF CANNULAENew Business Development, LLC2003-10-09GXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M661SST221505PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe cannula, single-useA rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Regulatory Flags#

DUNS number
118301171
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M661S013182759Guidewire Introducer NeedleS013182759L2024-06-18
M661S075173501Plastic Standard Hub Tuohy Epidural NeedleS07517-3.501B2024-06-18
M661S075175001Plastic Standard Hub Tuohy Epidural NeedleS07517-5.001B2024-06-18
M661S075183501Plastic Standard Hub Tuohy Epidural NeedleS07518-3.501B2024-06-18
M661S075185001Plastic Standard Hub Tuohy Epidural NeedleS07518-5.001B2024-06-18
M661S103417350Plastic BD Style Hub Tuohy Epidural Needle S103417-3.50NL2024-06-18
M661S103418350Plastic BD Style Hub Tuohy Epidural Needle S103418-3.50LT2024-06-18
M661S103418500Plastic BD Style Hub Tuohy Epidural Needle S10341-8.500LT2024-06-18
M661S135143508Metal Standard Hub Tuohy Epidural NeedleS13514-3.508C2024-06-18
M661S135144008Metal Standard Hub Tuohy Epidural NeedleS13514-4.008C2024-06-18
M661S135173008Metal Standard Hub Tuohy Epidural NeedleS13517-3.008B2024-06-18
M661S135173508Metal Standard Hub Tuohy Epidural NeedleS13517-3.508A2024-06-18
M661S135173828Metal Standard Hub Tuohy Epidural NeedleS13517-3.828A2024-06-18
M661S135175008Metal Standard Hub Tuohy Epidural NeedleS13517-5.008A2024-06-18
M661S135176008Metal Standard Hub Tuohy Epidural NeedleS13517-6.008B2024-06-18
M661S135183508Metal Standard Hub Tuohy Epidural NeedleS13518-3.508B2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleS80C21-6.00BLX2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleS80C22-2.00BLX2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleS80C23-2.00BL2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleS90C22-6.00BLX2024-06-18

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10195327047030Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2022-08-04
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00193493000159AVANOSAvanos Medical, Inc.GXI2021-03-11
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