K191739 is an FDA 510(k) clearance for the Sterile LeadConfirm. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Alpha Omega Engineering , Ltd. (Nazareth, IL). The FDA issued a Cleared decision on January 2, 2020, 188 days after receiving the submission on June 28, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K191739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2019 |
| Decision Date | January 02, 2020 |
| Days to Decision | 188 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 |