K230983 is an FDA 510(k) clearance for the Unicare (K-UNICARE-USA), a Stimulator, Electrical, Non-implantable, For Incontinence (Class II — Special Controls, product code KPI), submitted by Tenscare, Ltd. (Epsom, GB). The FDA issued a Cleared decision on October 20, 2023, 197 days after receiving the submission on April 6, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K230983 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 2023 |
| Decision Date | October 20, 2023 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPI — Stimulator, Electrical, Non-implantable, For Incontinence |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5320 |