K112709 is an FDA 510(k) clearance for the STIMULATION/DISSECTION INSTRUMENTS. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on February 9, 2012, 143 days after receiving the submission on September 19, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K112709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2011 |
| Decision Date | February 09, 2012 |
| Days to Decision | 143 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 |