Epimed
R-F™ Cobra Injector Cannula Coudé® 20g x 10cm w/ 10mm Active Tip
1manufacturer
100catalogue 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 | 2017-10-24 |
| Record revised | 2023-10-25 (version 8) |
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 | Case of 25, pack of 25, pack of 10, case of 5, case of 10 |
| Sizes | Length 5 to 15 cm; needle gauge 16 to 22 G; length 3 to 15 mm |
| Distribution end date | 2025-04-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 282-2210 | 22g | In distribution |
| 267-2015 | 20g | In distribution |
| 231-1810 | Needle Gauge 18 G | In distribution |
| 233-1610 | Needle Gauge 16 G | In distribution |
| 220-1810 | Length 10 cm | In distribution |
| 257-1615 | Length 15 cm | In distribution |
| 243-1810 | 10cm | In distribution |
| 282-2015 | 20g | In distribution |
| 241-2015 | 15cm | In distribution |
| 266-2210 | Needle Gauge 22 G | In distribution |
| 286-2205 | 22g | In distribution |
| 231-1610 | Needle Gauge 16 G | In distribution |
| 300-1815 | Length 10 mm | In distribution |
| 242-2205 | Needle Gauge 22 G | In distribution |
| 240-2205 | Needle Gauge 22 G | In distribution |
| 282-1810 | 18g | In distribution |
| 282-1615 | Length 15 cm | In distribution |
| 257-1610 | 10mm Active Tip | In distribution |
| 301-1815 | 10mm Active Tip | In distribution |
| 240-2010 | 10cm | In distribution |
| 243-1815 | Needle Gauge 18 G | In distribution |
| 267-2010 | 20g | In distribution |
| 281-2205 | 22g | In distribution |
| 266-2015 | 20g | In distribution |
| 287-1615 | 16g | In distribution |
| 287-1810 | 10 cm | In distribution |
| 261-2210 | 22g TW | In distribution |
| 301-1615 | Needle Gauge 16 G | In distribution |
| 287-2210 | 10 cm | In distribution |
| 243-2015 | Length 10 mm | In distribution |
| 262-2015 | 15cm | In distribution |
| 281-2210 | 10 cm | In distribution |
| 242-2210 | Needle Gauge 22 G | In distribution |
| 286-2015 | 5mm Active Tip | In distribution |
| 257-1815 | Length 15 cm | In distribution |
| 242-2010 | Length 5 mm | In distribution |
| 282-1815 | 18g | In distribution |
| 233-2010 | Needle Gauge 20 G | In distribution |
| 267-2215 | 22g TW | In distribution |
| 243-1610 | Needle Gauge 16 G | In distribution |
| 241-1815 | Length 10 mm | In distribution |
| 287-2015 | 20g | In distribution |
| 261-2010 | Length 5 mm | In distribution |
| 286-2010 | 20g | In distribution |
| 282-1610 | Length 10 mm | In distribution |
| 286-2005 | 20g TW | In distribution |
| 257-2010 | 10mm Active Tip | In distribution |
| 233-1810 | Length 10 mm | In distribution |
| 286-2210 | 22g | In distribution |
| 287-1815 | 18g | In distribution |
| 288-2010 | 20g RW | In distribution |
| 262-2215 | 22g TW | In distribution |
| 300-1615 | Length 10 mm | In distribution |
| 261-2215 | Length 15 cm | In distribution |
| 266-2215 | 15cm | In distribution |
| 287-1610 | 10 cm | In distribution |
| 240-2210 | Length 5 mm | In distribution |
| 241-1610 | 10mm Active Tip | In distribution |
| 281-2005 | Length 5 cm | In distribution |
| 262-2210 | Needle Gauge 22 G | In distribution |
| 267-2210 | 10cm | In distribution |
| 257-1810 | Length 10 cm | In distribution |
| 266-2010 | 20g | In distribution |
| 241-1810 | 18g | In distribution |
| 287-2010 | 20g | In distribution |
| 231-2010 | 20g | In distribution |
| 256-2205 | Length 5 mm | In distribution |
| 281-2015 | 20g | In distribution |
| 282-2010 | 10 cm | In distribution |
| 281-2010 | 10 cm | In distribution |
| 251-2010 | 20g | In distribution |
| 262-2010 | Needle Gauge 20 G | In distribution |
| 257-2015 | 10mm Active Tip | In distribution |
| 265-2010 | 20g TW | Withdrawn |
| 263-2215 | 22g TW | Withdrawn |
| 268-2210 | Needle Gauge 22 G | Withdrawn |
| 287-2215 | Length 10 mm | Withdrawn |
| 282-2215 | Needle Gauge 22 G | Withdrawn |
| 268-2015 | 20g TW | Withdrawn |
| 261-2015 | Length 15 cm | Withdrawn |
| 265-2210 | Length 3 mm | Withdrawn |
| 260-2010 | Needle Gauge 20 G | Withdrawn |
| 270-2015 | 15cm | Withdrawn |
| 263-2015 | 20g TW | Withdrawn |
| 263-2210 | 22g TW | Withdrawn |
| 231-1615 | Needle Gauge 16 G | Withdrawn |
| 261-2208 | 8.06cm | Withdrawn |
| 264-2208 | 8.06cm | Withdrawn |
| 250-2010 | 10cm | Withdrawn |
| 265-2015 | 15cm | Withdrawn |
| 260-2215 | Length 15 cm | Withdrawn |
| 281-2215 | 22g TW | Withdrawn |
| 260-2015 | Length 15 cm | Withdrawn |
| 263-2010 | 20g TW | Withdrawn |
| 270-2010 | Needle Gauge 20 G | Withdrawn |
| 260-2210 | Needle Gauge 22 G | Withdrawn |
| 220-2010 | 10mm Active Tip | Withdrawn |
| 268-2010 | 15mm Active Tip | Withdrawn |
| 233-1615 | Needle Gauge 16 G | Withdrawn |
| 286-2215 | 15cm | 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 |
| 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 |
|---|---|
| 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.