Sugita AVM Microclip Applier— 510(k) K221524

Name: FDA 510(k) clearance K221524
Creator: U.S. Food and Drug Administration
Published: 2022-06-24

Substantially Equivalent

Mizuho America, Inc.

FDA 510(k) clearance K221524 for Sugita AVM Microclip Applier, Substantially Equivalent on 2022-06-24. Applicant: Mizuho America, Inc.. Device class: 2.

Clearance details

Applicant: Mizuho America, Inc.
Product code: Code HCI
Device class: Class 2
Regulation: 21 CFR 882.4175
Advisory panel: Neurology
Date received: 2022-05-26
Decision date: 2022-06-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Union City, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.