FDA 510(k)

Sugita AVM Microclips

K-Number: K211183 · 2022-03-02

Decision Date2022-03-02

Product CodeHCH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Sugita AVM Microclips is the device name listed in this FDA 510(k) record. The listed applicant is Mizuho America, Inc.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K211183. The device is classified under product code HCH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sugita AVM Microclips?

Sugita AVM Microclips is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Mizuho America, Inc.. The 510(k) number is K211183.

When did Sugita AVM Microclips receive FDA 510(k) clearance?

Sugita AVM Microclips received FDA 510(k) clearance on 2022-03-02, under 510(k) number K211183.

Who is the listed applicant for Sugita AVM Microclips?

The FDA 510(k) record lists Mizuho America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sugita AVM Microclips?

The FDA product code for Sugita AVM Microclips is HCH.

Other records listing Mizuho America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221524Sugita AVM Microclip Applier

Related Devices (Code: HCH)

K180757D-Clip; D-Clip ApplierPeter Lazic GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.