K233576
- 510(k) number
- K233576
- Device name
- Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
- Applicant
- Shenzhen Konmed Technology Co., Ltd. CN
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2024-02-23
- Date received
- 2023-11-07
- 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: K233576
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.