K212164 is an FDA 510(k) clearance for the Mapping Suction Probe. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on November 11, 2022, 487 days after receiving the submission on July 12, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K212164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2021 |
| Decision Date | November 11, 2022 |
| Days to Decision | 487 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | ETN - Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |