K241516
- 510(k) number
- K241516
- Device name
- BTL-398
- Applicant
- BTL Industries, Inc. MA · US
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2025-02-10
- Date received
- 2024-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241516.pdf
Official FDA record: K241516
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.