Clearance Summary
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) received FDA 510(k) clearance under submission number K233576, sponsored by Shenzhen Konmed Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-02-23.
- Submission: K233576
- Applicant / Sponsor: Shenzhen Konmed Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 2024-02-23
Classification & Regulation
This clearance is catalogued under FDA product code KPI and 21 CFR 876.5320, within the Gastroenterology, Urology review panel as a Class II device.