Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013 +1 more— 510(k) K233576

Substantially Equivalent

Shenzhen Konmed Technology Co., Ltd.

FDA 510(k) clearance K233576 for Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013 +1 more, Substantially Equivalent on 2024-02-23. Applicant: Shenzhen Konmed Technology Co., Ltd.. Device class: 2.

Clearance details

Device name as filed
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.
Product code
Code KPI
Device class
Class 2
Regulation
21 CFR 876.5320
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pingshan District, Shenzhen, CN
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