Epimed International, Inc
RF Cobra Injector Cannula 20g x 10cm x 10mm Active Tip Straight
1manufacturer
5catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Epimed International, Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K041021 |
| Record published | 2025-11-21 |
| Record revised | 2024-02-21 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 50 to 90 °F |
| Packaging | Pack of 25, case of 25 |
| Sizes | Needle gauge 20 G; length 5 to 20 mm; length 5 to 10 cm |
| Distribution end date | 2024-02-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 259-2010 | Needle Gauge 20 G | In distribution |
| 258-2205 | Needle Gauge 20 G | In distribution |
| 284-2010 | Length 10 cm | In distribution |
| 233-2005 | 10cm | Withdrawn |
| 268-2010 | 20g | Withdrawn |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 |
|---|---|
| K190256 | 2019-03-08 |
| K041021 | 2004-09-16 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Epimed International, Inc. | 510(k) number | 2020-02-21 | Class II | Labeling design | Incorrect expiration date on introduction cannula packaging. | 1374 | 2021-01-28 |
| Epimed International, Inc. | 510(k) number | 2020-02-21 | Class II | Labeling design | Incorrect expiration date on introduction cannula packaging. | 701 | 2021-01-28 |
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.