Submission Details
| 510(k) Number | K231580 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 31, 2023 |
| Decision Date | August 30, 2023 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
NIM? 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
Aug 2023
Decision
91d
Days
Class 2
Risk
About This 510(k) Submission
K231580 is an FDA 510(k) clearance for the NIM? 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35), a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 30, 2023, 91 days after receiving the submission on May 31, 2023. 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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