The following data is part of a premarket notification filed by Biomerics with the FDA for Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode.
| Device ID | K121773 |
| 510k Number | K121773 |
| Device Name: | NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | BIOMERICS 2700 S 900 W Salt Lake City, UT 84119 |
| Contact | Emily Madsen |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-06-18 |
| Decision Date | 2012-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B452NIM15010BB1 | K121773 | 000 |
| 10850040767015 | K121773 | 000 |
| 10850040767022 | K121773 | 000 |
| 10850040767039 | K121773 | 000 |
| B452NIM05010BB0 | K121773 | 000 |
| B452NIM05010BB1 | K121773 | 000 |
| B452NIM10010BB0 | K121773 | 000 |
| B452NIM10010BB1 | K121773 | 000 |
| B452NIM10010BBCS0 | K121773 | 000 |
| B452NIM10010BBCS1 | K121773 | 000 |
| B452NIM15010BB0 | K121773 | 000 |
| 10850040767008 | K121773 | 000 |