K181544 is an FDA 510(k) clearance for the Anchor Bolt (as an accessory to Depth Electrodes). This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Ad-Tech Medical Instrument Corporation (Oak Creek, US). The FDA issued a Cleared decision on August 9, 2018, 58 days after receiving the submission on June 12, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K181544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2018 |
| Decision Date | August 09, 2018 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL - Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |