Cleared Traditional

K211183 - Sugita AVM Microclips

K211183 is an FDA 510(k) clearance for Sugita AVM Microclips, manufactured by Mizuho America, Inc.. The device is a Class 2 Neurology device with product code HCH cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K211183 · Mizuho America, Inc. · Neurology device
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Mar 2022
Decision
316d
Days
Class 2
Risk

K211183 is an FDA 510(k) clearance for the Sugita AVM Microclips. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Mizuho America, Inc. (Union City, US). The FDA issued a Cleared decision on March 2, 2022 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5200 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mizuho America, Inc. devices

FDA 510(k) Submission Details - K211183

510(k) Number K211183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2021
Decision Date March 02, 2022
Days to Decision 316 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 148d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCH Device Classification - Class 2, Special Controls

Product Code HCH Clip, Aneurysm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HCH Clip, Aneurysm

All 20
Devices cleared under the same product code (HCH) and FDA review panel - the closest regulatory comparables to K211183.
D-Clip
K180757 · Peter Lazic GmbH · Apr 2019
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
K131500 · Aesculap, Inc. · Jan 2014
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
K091921 · Codman & Shurtleff, Inc. · Sep 2009
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
K043041 · Aesculap, Inc. · Dec 2004
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · Aesculap, Inc. · Aug 2003
TEMPORARY TITANIUM ANEURYSM CLIP
K031468 · Cardinalhealth · Jun 2003