K110422 is an FDA 510(k) clearance for the SURGICAL STIMULATORS. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on May 26, 2011, 101 days after receiving the submission on February 14, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K110422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2011 |
| Decision Date | May 26, 2011 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |