SideKick™ 2
Siliconized 15cm x 10mm x 18ga (1.2mm)
1manufacturer
4catalogue numbers in this listing
9recalls 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 | Boston Scientific Neuromodulation Corporation, United States |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2021-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RFK-C151018S-ZK2 | 15cm x 10mm x 18ga (1.2mm) | In distribution |
| RFK-C101018S-ZK2 | 10cm x 10mm x 18ga (1.2mm) | In distribution |
| RFK-C101020S-ZK2 | 10cm x 10mm x 20ga (0.9mm) | In distribution |
| RFK-C151020S-ZK2 | 15cm x 10mm x 20ga (0.9mm) | 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 |
| Lccs | Lccs Products Limited | 101 |
| 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 |
Showing 12 of 85. All products under Probe, Radiofrequency Lesion
Recalls
9 of these are 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 |
|---|---|---|---|---|---|
| 2026-04-29 | Class II | Under Investigation by firm | Reusable electrodes may not meet expected performance levels. | 49,251 units | |
| 2026-04-29 | Class II | Under Investigation by firm | Reusable electrodes may not meet expected performance levels. | 31,923 units | |
| 2026-04-22 | Class II | Packaging process control | Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection. | 37,764 | |
| 2019-05-30 | Class II | Error in labeling | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products. | 43 units | 2021-04-28 |
| 2019-05-30 | Class II | Error in labeling | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products. | 437 units | 2021-04-28 |
| 2019-05-30 | Class II | Error in labeling | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products. | 118 units | 2021-04-28 |
| 2019-05-30 | Class II | Error in labeling | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products. | 110 units | 2021-04-28 |
| 2019-05-30 | Class II | Error in labeling | The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products. | 40 units | 2021-04-28 |
| 2017-07-05 | Class II | Device Design | After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning | 11250 units (10,460 USA; 790 OUS) | 2018-09-14 |
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.