IceCap product line
K-Number: K243788 · 2025-03-13
ApplicantBioserenity Medical Devices Group
Decision Date2025-03-13
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
IceCap product line is a medical device manufactured by Bioserenity Medical Devices Group. It received FDA 510(k) clearance on 2025-03-13 under approval number K243788. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IceCap product line?
IceCap product line is a medical device that received FDA 510(k) clearance on 2025-03-13. It is manufactured by Bioserenity Medical Devices Group. The 510(k) number is K243788.
When was IceCap product line approved by the FDA?
IceCap product line received FDA 510(k) clearance on 2025-03-13, under approval number K243788.
What company makes IceCap product line?
IceCap product line is manufactured by Bioserenity Medical Devices Group.
What is the FDA product code for IceCap product line?
The FDA product code for IceCap product line is GXY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.