Lccs
The FDA filing describes the LCCS Radiofrequency Electrode as an electrode used with an RF generator to create lesions in nerve tissue or for percutaneous nerve blocks. It names both…
The FDA filing describes the LCCS Radiofrequency Electrode as an electrode used with an RF generator to create lesions in nerve tissue or for percutaneous nerve blocks. It names both disposable and reusable LCCS electrode lines.
The filing states that the electrodes are used for temperature-controlled heat lesioning of peripheral nerve tissue. It lists separate part-number groups for the disposable and reusable versions.
Listed Item
LCCS Radiofrequency (RF) Electrode
Electrode Versions
The submission describes the device family rather than assigning every dimensional or construction detail to each listed electrode. The FDA filing’s stated use is limited to the described nerve-tissue lesioning and percutaneous nerve-block contexts.
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 | Lccs Products Limited, Hong Kong |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K152642 |
| Record published | 2020-01-01 |
| Record revised | 2023-05-03 (version 3) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 40, box of 25, pack of 25, pack of 40, box of 5, carton of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RE27150-D-LC | In distribution | |
| S-1005-S-22-LC | In distribution | |
| C-1010-S-16-LC | In distribution | |
| C-1510-Y-22-LC | In distribution | |
| C-1510-S-18-LC | In distribution | |
| S-1510-18-LC | In distribution | |
| C-505-20-LC | In distribution | |
| RE2550-R-LC | In distribution | |
| S-1007-18-LC | In distribution | |
| C-1505-S-20-LC | In distribution | |
| C-505-B-22-LC | In distribution | |
| RE25150-R-LC | In distribution | |
| C-1010-B-20-LC | In distribution | |
| C-1510-Y-18-LC | In distribution | |
| C-1010-S-22-LC | In distribution | |
| S-1505-22-LC | In distribution | |
| C-1015-Y-20-LC | In distribution | |
| C-1005-S-22-LC | In distribution | |
| S-1510-22-LC | In distribution | |
| C-1010-B-22-LC | In distribution | |
| C-1010-Y-16-LC | In distribution | |
| C-1510-S-22-LC | In distribution | |
| S-1010-22-LC | In distribution | |
| S-510-20-LC | In distribution | |
| C-1010-Y-18-LC | In distribution | |
| S-1005-S-20-LC | In distribution | |
| C-1515-Y-20-LC | In distribution | |
| C-1005-S-20-LC | In distribution | |
| C-1005-18-LC | In distribution | |
| C-502-22-LC | In distribution | |
| C-1005-R-20-LC | In distribution | |
| S-1005-20-LC | In distribution | |
| C-1010-18-LC | In distribution | |
| C-1510-B-20-LC | In distribution | |
| C-1515-B-22-LC | In distribution | |
| S-502-22-LC | In distribution | |
| C-1502-22-LC | In distribution | |
| C-1515-Y-22-LC | In distribution | |
| RE25100-D-LC | In distribution | |
| RE25200-D-LC | In distribution | |
| C-1010-R-22-LC | In distribution | |
| C-505-B-20-LC | In distribution | |
| RE27200-D-LC | In distribution | |
| C-1005-B-20-LC | In distribution | |
| RE27200-R-LC | In distribution | |
| C-510-20-LC | In distribution | |
| C-1015-Y-18-LC | In distribution | |
| C-510-Y-16-LC | In distribution | |
| C-1505-S-18-LC | In distribution | |
| S-510-22-LC | In distribution | |
| C-505-22-LC | In distribution | |
| C-1005-R-22-LC | In distribution | |
| S-1010-18-LC | In distribution | |
| C-1010-Y-20-LC | In distribution | |
| RE27100-R-LC | In distribution | |
| S-1510-20-LC | In distribution | |
| C-510-Y-18-LC | In distribution | |
| C-1510-S-20-LC | In distribution | |
| S-1505-18-LC | In distribution | |
| C-510-22-LC | In distribution | |
| C-1505-20-LC | In distribution | |
| S-1005-18-LC | In distribution | |
| S-1502-20-LC | In distribution | |
| RE2750-D-LC | In distribution | |
| S-1005-22-LC | In distribution | |
| RE2750-R-LC | In distribution | |
| C-1505-B-20-LC | In distribution | |
| RE25150-D-LC | In distribution | |
| S-2005-20-LC | In distribution | |
| C-1510-Y-20-LC | In distribution | |
| RE25100-R-LC | In distribution | |
| S-1015-22-LC | In distribution | |
| C-1510-18-LC | In distribution | |
| RE2550-D-LC | In distribution | |
| C-1510-S-16-LC | In distribution | |
| C-1010-S-20-LC | In distribution | |
| C-1510-B-22-LC | In distribution | |
| RE25200-R-LC | In distribution | |
| S-1010-S-20-LC | In distribution | |
| C-1010-R-20-LC | In distribution | |
| C-1010-S-18-LC | In distribution | |
| C-1515-Y-18-LC | In distribution | |
| C-1510-Y-16-LC | In distribution | |
| S-505-20-LC | In distribution | |
| C-510-Y-20-LC | In distribution | |
| S-1002-22-LC | In distribution | |
| S-1010-S-22-LC | In distribution | |
| S-1010-20-LC | In distribution | |
| C-1005-S-18-LC | In distribution | |
| C-1515-Y-16-LC | In distribution | |
| RE27100-D-LC | In distribution | |
| C-505-18-LC | In distribution | |
| C-510-18-LC | In distribution | |
| S-2010-20-LC | In distribution | |
| S-505-22-LC | In distribution | |
| C-1015-Y-22-LC | In distribution | |
| C-1010-Y-22-LC | In distribution | |
| C-1015-Y-16-LC | In distribution | |
| RE27150-R-LC | In distribution | |
| C-1505-B-22-LC | In distribution | |
| C-510-Y-22-LC | In distribution |
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 |
| Epimed | Epimed International, Inc. | 100 |
| Avanos | Avanos Medical, Inc. | 89 |
| NeuroTherm™ | Neurotherm, Inc. | 87 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191293 | 2020-01-24 |
| K152642 | 2016-08-26 |
| K112231 | 2011-08-19 |
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.