Intracept
Contains: (1) Intracept Flexible Bi-Polar RF Probe and (1) Intracept Access Instruments - Trocar
1manufacturer
15catalogue numbers in this listing
6510(k) clearances naming this product 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 | Relievant Medsystems, United States |
|---|---|
| FDA product code | GXI |
| Device type | Probe, Radiofrequency Lesion |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4725 |
| Record published | 2018-04-01 |
| Record revised | 2025-08-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 120 °F |
| Packaging | Pack of 5, pack of 3 |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RLV 0035 | In distribution | |
| RLV 0055 | In distribution | |
| RLV0065 | In distribution | |
| RLV 0020 | In distribution | |
| RLV 0045 | In distribution | |
| RLV 0075 | In distribution | |
| FG 0046 | Withdrawn | |
| RLV PK | Withdrawn | |
| FG 0043 | Withdrawn | |
| RLV PKBLR | Withdrawn | |
| FG 0054 | Withdrawn | |
| FG 0045 | Withdrawn | |
| FG 0060 | Withdrawn | |
| RLV PKTLR | Withdrawn | |
| FG 0038 | Withdrawn |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 |
|---|---|
| K222281 | 2022-10-26 |
| K213836 | 2022-03-11 |
| K190504 | 2019-05-03 |
| K180369 | 2018-09-14 |
| K170827 | 2017-08-09 |
| K153272 | 2016-07-09 |
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.