K200886 is an FDA 510(k) clearance for the StimSite. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Allotrope Medical, Inc. (Houston, US). The FDA issued a Cleared decision on November 10, 2020, 222 days after receiving the submission on April 2, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K200886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2020 |
| Decision Date | November 10, 2020 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | ETN - Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |