K200848 is an FDA 510(k) clearance for the Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II - Special Controls, product code GZF).
Submitted by Micron Medical Corporation (Boca Raton, US). The FDA issued a Cleared decision on August 14, 2020, 136 days after receiving the submission on March 31, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.
| 510(k) Number | K200848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2020 |
| Decision Date | August 14, 2020 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZF - Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5870 |