NeuroTherm™
Radiofrequency Cannula - Straight Radiopaque
1manufacturer
87catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Neurotherm, Inc. |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| 510(k) | K042375 |
| Record published | 2015-09-14 |
| Record revised | 2023-10-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store in a cool, dry place; avoid exposure to extreme temperatures. |
| Packaging | Pack of 10, pack of 5 |
| Sizes | Needle gauge 16 to 22 G; length 5 to 20 cm |
| Distribution end date | 2020-04-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CLASSIC | Needle Gauge 18 G | In distribution |
| RFDE-5 | Length 5 cm | In distribution |
| SMK | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SMK | Length 10 cm | In distribution |
| SMK | Length 10 cm | In distribution |
| SMK | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| SL | Needle Gauge 22 G | In distribution |
| SL | Needle Gauge 20 G | In distribution |
| SMK | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 18 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SL | Needle Gauge 20 G | In distribution |
| SL | Needle Gauge 20 G | In distribution |
| SL | Needle Gauge 22 G | In distribution |
| RFDEUK-10 | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| PT-KIT-S | In distribution | |
| CLASSIC | Needle Gauge 18 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 16 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| RFE-15-S | Length 15 cm | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| SL | Needle Gauge 18 G | In distribution |
| S-1010-B-18 | Needle Gauge 18 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SL | Needle Gauge 22 G | In distribution |
| SL | Needle Gauge 20 G | In distribution |
| NRFE-15 | Length 15 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| RFE-5-S | Length 5 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| RFE-5 | Length 5 cm | In distribution |
| RFE-10-S | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 18 G | In distribution |
| SL | Needle Gauge 22 G | In distribution |
| NRFE-5 | Length 5 cm | In distribution |
| CLASSIC | Needle Gauge 16 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| RFE-20 | Length 20 cm | In distribution |
| SL | Needle Gauge 20 G | In distribution |
| RFDE-20 | Length 20 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SL | Needle Gauge 18 G | In distribution |
| SMK | Needle Gauge 22 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| SMK | Length 10 cm | In distribution |
| SMK | Length 15 cm | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SL | Needle Gauge 22 G | In distribution |
| SMK | Length 15 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SMK | Length 10 cm | In distribution |
| NRFE-10 | Length 10 cm | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| SMK | Needle Gauge 22 G | In distribution |
| SMK | Needle Gauge 20 G | In distribution |
| SL | Needle Gauge 20 G | In distribution |
| SMK | Needle Gauge 18 G | In distribution |
| CLASSIC | Needle Gauge 22 G | In distribution |
| SL | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| S-1510-B-18 | Needle Gauge 18 G | In distribution |
| CLASSIC | Needle Gauge 18 G | In distribution |
| RFE-15 | Length 15 cm | In distribution |
| SL | Needle Gauge 22 G | In distribution |
| SL | Needle Gauge 20 G | In distribution |
| CLASSIC | Needle Gauge 20 G | In distribution |
| RFE-10 | Length 10 cm | In distribution |
| RFDEUK-15 | Length 15 cm | Withdrawn |
| RFDEUK-20 | Length 20 cm | Withdrawn |
| RFDE-10 | Length 10 cm | Withdrawn |
| CLASSIC | Needle Gauge 21 G | Withdrawn |
| RFDE-15 | Length 15 cm | Withdrawn |
| RFDEUK-5 | Length 5 cm | Withdrawn |
| CLASSIC | Needle Gauge 22 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OWL | Diros Technology, Inc. | 345 |
| Probe, Radiofrequency Lesion | Boston Scientific Neuromodulation Corporation | 175 |
| Halyard | Avanos Medical, Inc. | 156 |
| Lccs | Lccs Products Limited | 101 |
| Epimed | Epimed International, Inc. | 100 |
| Avanos | Avanos Medical, Inc. | 89 |
| Probe, Radiofrequency Lesion | St. Jude Medical | 66 |
| cannulaRFK | Cosman Medical, Inc. | 56 |
| Rftl | Pajunk Gmbh Medizintechnologie | 54 |
| Radiofrequency (RF) Needle | Spectra Medical Devices, LLC | 49 |
| cannulaCC | Cosman Medical, Inc. | 47 |
| Epimed | Minta Medical Limited | 35 |
Showing 12 of 85. All products under Probe, Radiofrequency Lesion
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-02-26 | Class II | Process control | Straight needle labeled as a curved needle | 135 cannulas (27 boxes/5) | 2016-03-25 |
| 2008-07-28 | Not classified | Labeling design | Distal tip may detach from the probe | 71 units | 2009-09-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.