Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sugita AVM Microclip Applier

K-Number: K221524 · 2022-06-24

ApplicantMizuho America, Inc.
Decision Date2022-06-24
Product CodeHCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sugita AVM Microclip Applier is a medical device manufactured by Mizuho America, Inc.. It received FDA 510(k) clearance on 2022-06-24 under approval 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. It is manufactured by Mizuho America, Inc.. The 510(k) number is K221524.

When was Sugita AVM Microclip Applier approved by the FDA?

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

What company makes Sugita AVM Microclip Applier?

Sugita AVM Microclip Applier is manufactured by Mizuho America, Inc..

What is the FDA product code for Sugita AVM Microclip Applier?

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

Other Devices by Mizuho America, Inc.

K211183Sugita AVM Microclips

Related Devices (Code: HCI)

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

↑