FDA 510(k)

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)

Número K: K233576 · 2024-02-23

RequerenteShenzhen Konmed Technology Co., Ltd.

Data da decisão2024-02-23

Código do produtoKPI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K233576. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)?

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K233576.

When did Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) receive FDA 510(k) clearance?

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 on 2024-02-23, under 510(k) number K233576.

Who is the listed applicant for Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)?

The FDA 510(k) record lists Shenzhen Konmed Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)?

The FDA product code for Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) is KPI.

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Fonte oficial

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