Submission Details
| 510(k) Number | K213246 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2021 |
| Decision Date | March 21, 2022 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
Mar 2022
Decision
172d
Days
Class 2
Risk
About This 510(k) Submission
K213246 is an FDA 510(k) clearance for the NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 21, 2022, 172 days after receiving the submission on September 30, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.
Device Classification
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.1820 |
Manufacturer
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