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Q'Apel Medical, Inc. manufactured the 072 Aspiration System (HIPPO), a medical device intended for treating acute ischemic stroke, without obtaining required FDA premarket approval or an investigational device exemption, rendering the device adulterated under federal law. The company also failed to notify FDA of its intent to introduce the device into commercial distribution as required by section 510(k) of the Federal Food, Drug, and Cosmetic Act, making the device misbranded. An FDA inspection conducted July 29 through August 8, 2024, at the company's Fremont, California facility identified these violations.