Cleared Special

Sugita AVM Microclip Applier

K221524 · Mizuho America, Inc. · Neurology
Jun 2022
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K221524 is an FDA 510(k) clearance for the Sugita AVM Microclip Applier, a Applier, Aneurysm Clip (Class II — Special Controls, product code HCI), submitted by Mizuho America, Inc. (Union City, US). The FDA issued a Cleared decision on June 24, 2022, 29 days after receiving the submission on May 26, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4175.

Submission Details

510(k) Number K221524 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2022
Decision Date June 24, 2022
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCI — Applier, Aneurysm Clip
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4175

Similar Devices — HCI Applier, Aneurysm Clip

All 13
Aesculap Slim Clip Applier
K211572 · Aesculap, Inc. · Dec 2021
Aesculap Slim Clip Applier
K180914 · Aesculap, Inc. · Apr 2018
Aesculap Slim Clip Applier Forceps
K173271 · Aesculap, Inc. · Nov 2017
MEDICON YASARGIL CLIP APPLYING FORCEPS
K010910 · Medicon EG · Aug 2001
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
K994191 · Nmt Medical, Inc. · Feb 2000
AESCULAP AXIAL CLIP APPLIER
K984109 · Aesculap, Inc. · Feb 1999