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FDA 510(k)

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 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.

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. 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.

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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