Submission Details
| 510(k) Number | K212164 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Mapping Suction Probe
Nov 2022
Decision
487d
Days
Class 2
Risk
About This 510(k) Submission
K212164 is an FDA 510(k) clearance for the Mapping Suction Probe, 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 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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