Rftl Sono
RFTL Sono 22G x 98,6mm, with Cornerstone reflectors
1manufacturer
7catalogue numbers in this listing
1510(k) clearance
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 | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K060397 |
| Record published | 2025-11-04 |
| Record revised | 2025-12-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment humidity 20 to 65 % RH |
| Packaging | Pack of 25 |
| Sizes | Needle gauge 20 G; length 52.6 mm |
| Distribution end date | 2025-11-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 001175-20B | In distribution | ||
| 001175-11D | Needle Gauge 20.0 G | In distribution | |
| 001175-20A | In distribution | ||
| 001175-20B | 25 | Withdrawn | |
| 001175-20A | 25 | Withdrawn | |
| 001175-20A | 25 | Withdrawn | |
| 001175-20B | 25 | Withdrawn |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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060397 | 2006-08-31 |
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.