510(k) clearance
BTL-299-F
- 510(k) number
- K262353
- Applicant
- BTL Industries, Inc.
- Decision date
- Sep 23, 2026
- Date received
- Jul 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KPI
- Device type
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device class
- Class II
- Regulation
- 21 CFR 876.5320
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Marlborough, MA, US