Model: Cura RF Electrode Fixed 18-10s20FD
DI: 06937278649393
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Cura RF Electrode
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
760fab0e-70bf-4571-b31a-38d452b0b747
Distribution Status:
In Commercial Distribution
DUNS Number:
412923111
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
16937278649390
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06937278649393
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06937278649393
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 61933
Name: Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Definition:
A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.
FDA Product Codes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
Premarket Submissions
Submission Number:
K240758
Supplement Number:
000