K252831
- 510(k) number
- K252831
- Device name
- Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- Applicant
- Dolanvy (Suzhou) Medical Technology Co., Ltd. CN
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2026-04-28
- Date received
- 2025-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K252831
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.