Radiofrequency (RF) Needle

GUDID M661SCV221005

22G x 10cm x 5mm Active Tip Sharp RF Needle, No Echogenic Tip, Lubrication Curved, Black Cap

Spectra Medical Devices, LLC

Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use

• Primary Device ID: M661SCV221005
• NIH Device Record Key: 43cc1133-8d26-4f7d-bfdb-30e4ddd87757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiofrequency (RF) Needle
• Version Model Number: SCV221005SL
• Company DUNS: 118301171
• Company Name: Spectra Medical Devices, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M661SCV221005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032196

FDA Product Code

• GXI: Probe, Radiofrequency Lesion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-26
• Device Publish Date: 2024-06-18

On-Brand Devices [Radiofrequency (RF) Needle]

• M661SCV201010: 20G x 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow
• M661SCV200510: 20G x 5cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubricated, Curved, Yellow Cap
• M661SCV200505: 20G x 5cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow Cap
• M661SCV181510: 18G x 15cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubricated, Curved, Pink Cap
• M661SCV181010: 18G x 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubricated, Curved, Pink Cap
• M661SST211005: 21G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Green
• M661SST201505: 20G x 15cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, No Lubrication, Straight, Yellow
• M661SST201005: 20G x 10cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, No Lubrication, Straight, Yellow
• M661SCV181005: 18G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Curved, Pink Cap
• M661SCV161510: 16G x 15cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Purple
• M661SCV161010: 16G x 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Purple
• M661SBC201010: 20G x 10cm x 10mm Active Tip, Blunt RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow
• M661S221505STSQ1: 22G x 15cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Straight, Black Cap
• M661S221010CVSQ1: 22G x 10cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Curved, Black Cap
• M661S201510STSQ1: 20G x 15cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Straight, Yellow Ca
• M661S201510CVSQ1: 20G x 15cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Curved, Yellow Cap
• M661S201505STSQ1: 20G x 15cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Straight, Yellow Cap
• M661S201505CVSQ1: 20G x 15cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Curved, Yellow Cap
• M661S201010STSQ1: 20G x 10cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Straight, Yellow Ca
• M661S201010CVSQ1: 20G x 10cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Curved, Yellow Cap
• M661S181510STSQ1: 20G x 10cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Curved, Yellow Cap
• M661S181510CVSQ1: 18G x 15cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Curved, Pink Cap
• M661S181505STSQ1: 18G x 15cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Straight, Pink Cap
• M661S181505CVSQ1: 18G x 15cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip & Lub, Curved, Pink Cap
• M661SST221010: 22G x 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black
• M661SST221005: 22G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black C
• M661SST220510: 22G x 5cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black C
• M661SST220504: 22G x 5cm x 4mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Black Ca
• M661SST211010: 21G x 10cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, No Lubrication, Straight, Green
• M661SST210505: 21G x 5cm x 5mm Active Tip, Sharp RF Needle, Echogenic Tip, No Lubrication, Straight, Green Ca
• M661SST210504: 21G x 5cm x 4mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Green C
• M661SST201520: 20G x 15cm x 20mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Yello
• M661SST201515: 20G x 15cm x 15mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Yello
• M661SST201510: 20G x 15cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Yellow
• M661SST201010: 20G x 10cm x 10mm Active Tip Sharp RF Needle, No Echogenic Tip, Lubrication Straight, Yellow Cap
• M661SST181510: 18G x 15cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Pink C
• M661SST181505: 18G x 15cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Pink C
• M661SST181010: 18G 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Straight, Pink Ca
• M661SST181005: 18G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Straight, Pink Ca
• M661SCV221010: 22G x 10cm x 10mm Active Tip Sharp RF Needle, No Echogenic Tip, Lubrication Curved, Black Cap
• M661SCV221005: 22G x 10cm x 5mm Active Tip Sharp RF Needle, No Echogenic Tip, Lubrication Curved, Black Cap
• M661SCV220510: 22G x 5cm x 10mm Active Tip Sharp RF Needle, No Echogenic Tip, Lubrication Curved, Black Cap
• M661SCV220505: 22G x 5cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Curved, Black Cap
• M661SCV201515: 20G x 15cm x 15mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow
• M661SCV201510: 20G x 15cm x 10mm Active Tip Sharp RF Needle, No Echogenic Tip, Lubrication Curved, Yellow Cap
• M661SCV201505: 20G x 15cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow Ca
• M661SCV201005: 20G x 10cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow C
• M661SCV181505: 18G x 15cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubrication, Curved, Pink Cap