FDA 510(k)

Sugita AVM Microclip Applier

K-Number: K221524 · 2022-06-24

Decision Date2022-06-24

Product CodeHCI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Sugita AVM Microclip Applier 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 2022-06-24 under 510(k) number K221524. The device is classified under product code HCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sugita AVM Microclip Applier?

Sugita AVM Microclip Applier is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Mizuho America, Inc.. The 510(k) number is K221524.

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

Sugita AVM Microclip Applier received FDA 510(k) clearance on 2022-06-24, under 510(k) number K221524.

Who is the listed applicant for Sugita AVM Microclip Applier?

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 Microclip Applier?

The FDA product code for Sugita AVM Microclip Applier is HCI.

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.

K211183Sugita AVM Microclips

Related Devices (Code: HCI)

K211572Aesculap Slim Clip ApplierAesculap, Inc.K180914Aesculap Slim Clip ApplierAesculap, Inc.K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc.

Official Source

View on FDA Database →

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