K013215 is an FDA 510(k) clearance for the MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM. This device is classified as a Stimulator, Nerve, Ac-powered (Class II - Special Controls, product code BXM).
Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on October 16, 2001, 20 days after receiving the submission on September 26, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K013215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2001 |
| Decision Date | October 16, 2001 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BXM — Stimulator, Nerve, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |