The following data is part of a premarket notification filed by Biomerics with the FDA for Vesta Rf Cannula.
| Device ID | K190259 |
| 510k Number | K190259 |
| Device Name: | Vesta RF Cannula |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Biomerics 6030 West Harold Gatty Drive Salt Lake City, UT 84116 |
| Contact | Jake Wakley |
| Correspondent | Jake Wakley Biomerics 6030 West Harold Gatty Drive Salt Lake City, UT 84116 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-07 |
| Decision Date | 2020-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40850040767238 | K190259 | 000 |
| 50850040767129 | K190259 | 000 |
| 40850040767115 | K190259 | 000 |
| 40850040767108 | K190259 | 000 |
| 10850040767251 | K190259 | 000 |
| 40850040767085 | K190259 | 000 |
| 40850040767078 | K190259 | 000 |
| 40850040767061 | K190259 | 000 |
| 40850040767054 | K190259 | 000 |
| 40850040767139 | K190259 | 000 |
| 40850040767146 | K190259 | 000 |
| 40850040767221 | K190259 | 000 |
| 40850040767214 | K190259 | 000 |
| 40850040767207 | K190259 | 000 |
| 40850040767191 | K190259 | 000 |
| 40850040767184 | K190259 | 000 |
| 40850040767177 | K190259 | 000 |
| 40850040767160 | K190259 | 000 |
| 50850040767150 | K190259 | 000 |
| 50850040767044 | K190259 | 000 |