The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nim Surgeon Control Probe, Prass Tip, Nim Surgeon Control Probe, 1mm Ball Tip, Nim Surgeon Control Probe, 1mm Ball Tip, 35cm Long.
| Device ID | K213246 |
| 510k Number | K213246 |
| Device Name: | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long |
| Classification | Stimulator, Nerve |
| Applicant | Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 |
| Contact | Alexandra Oliver |
| Correspondent | Alexandra Oliver Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000112455 | K213246 | 000 |
| 00763000112448 | K213246 | 000 |
| 00763000112462 | K213246 | 000 |