K241516 is an FDA 510(k) clearance for the BTL-398. This device is classified as a Stimulator, Electrical, Non-implantable, For Incontinence (Class II - Special Controls, product code KPI).
Submitted by BTL Industries, Inc. (Marlborough, US). The FDA issued a Cleared decision on February 10, 2025, 257 days after receiving the submission on May 29, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K241516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2024 |
| Decision Date | February 10, 2025 |
| Days to Decision | 257 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 |