Cleared Traditional

IceCap product line

K243788 · Bioserenity Medical Devices Group · Neurology

Mar 2025

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K243788 is an FDA 510(k) clearance for the IceCap product line, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bioserenity Medical Devices Group (Paris, FR). The FDA issued a Cleared decision on March 13, 2025, 94 days after receiving the submission on December 9, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K243788 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2024
Decision Date	March 13, 2025
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF