K171807 is an FDA 510(k) clearance for the ES2 Neuromonitoring Accessory Instruments. This device is classified as a Neurosurgical Nerve Locator (Class II - Special Controls, product code PDQ).
Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on July 18, 2017, 29 days after receiving the submission on June 19, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 874.1820. To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery..
| 510(k) Number | K171807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2017 |
| Decision Date | July 18, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PDQ — Neurosurgical Nerve Locator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |
| Definition | To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery. |