FDA 510(k)

IceCap product line

Número K: K243788 · 2025-03-13

RequerenteBioserenity Medical Devices Group

Data da decisão2025-03-13

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

IceCap product line is the device name listed in this FDA 510(k) record. The listed applicant is Bioserenity Medical Devices Group. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K243788. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IceCap product line?

IceCap product line is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Bioserenity Medical Devices Group. The 510(k) number is K243788.

When did IceCap product line receive FDA 510(k) clearance?

IceCap product line received FDA 510(k) clearance on 2025-03-13, under 510(k) number K243788.

Who is the listed applicant for IceCap product line?

The FDA 510(k) record lists Bioserenity Medical Devices Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IceCap product line?

The FDA product code for IceCap product line is GXY.

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