K133348 is an FDA 510(k) clearance for the STIM PROBE. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on November 21, 2014, 387 days after receiving the submission on October 30, 2013.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K133348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2013 |
| Decision Date | November 21, 2014 |
| Days to Decision | 387 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 |