HCI · Class II · 21 CFR 882.4175

FDA Product Code HCI: Applier, Aneurysm Clip

Leading manufacturers include Mizuho America, Inc. and Aesculap, Inc..

14
Total
14
Cleared
114d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Applier, Aneurysm Clip Devices (Product Code HCI)

14 devices
1–14 of 14
Cleared Jun 24, 2022
Sugita AVM Microclip Applier
K221524
Mizuho America, Inc.
Neurology · 29d
Cleared Dec 13, 2021
Aesculap Slim Clip Applier
K211572
Aesculap, Inc.
Neurology · 206d

About Product Code HCI - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code HCI since 1983, with 14 receiving FDA clearance (average review time: 114 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

HCI devices are reviewed by the Neurology panel. Browse all Neurology devices →