K031003 is an FDA 510(k) clearance for the STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 11, 2003, 11 days after receiving the submission on March 31, 2003.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K031003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2003 |
| Decision Date | April 11, 2003 |
| Days to Decision | 11 days |
| Submission Type | Special |
| 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 |