Device product
Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.
Z-1247-2016
Product summary
- Firm
- Neurotherm, Inc.
- Event
- Event 73407
- Status
- Terminated
- Classification
- Class II
- Quantity
- 135 cannulas (27 boxes/5)
- Official record key
device-enforcement:Z-1247-2016
Official wording
Reason: Straight needle labeled as a curved needle
Code information: Lot number: 12131-1C
Distribution pattern: US Nationwide Distribution in the states of CA ,CO, OH, OR
Derived failure modes
-
Unknown
Straight needle labeled as a curved needle