Submission Details
| 510(k) Number | K223254 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 21, 2022 |
| Decision Date | January 27, 2023 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
C2 Xplore
Jan 2023
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K223254 is an FDA 510(k) clearance for the C2 Xplore, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on January 27, 2023, 98 days after receiving the submission on October 21, 2022. 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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