Q’Apel Medical, Inc.

Warning LetterOpen

United StatesFEI 3015614180Issued Feb 5, 2025Center for Devices and Radiological Health

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Violations5

Issue DateFeb 5, 2025

Product TypeDevices

StatusOpen

Letter Details

Firm: Q’Apel Medical, Inc.
Location: United States
FEI Number: 3015614180
Country: United States
Issue Date: February 05, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Devices
Status: Open

Summary

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.

Q’Apel Medical, Inc. FDA Warning Letter, February 5, 2025