Cleared Traditional

SUGITA AVM MICROCLIP

K960037 · Mizuho America, Inc. · Neurology
Feb 1997
Decision
399d
Days
Class 2
Risk

About This 510(k) Submission

K960037 is an FDA 510(k) clearance for the SUGITA AVM MICROCLIP, a Clip, Aneurysm (Class II — Special Controls, product code HCH), submitted by Mizuho America, Inc. (Beverly, US). The FDA issued a Cleared decision on February 5, 1997, 399 days after receiving the submission on January 3, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5200.

Submission Details

510(k) Number K960037 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1996
Decision Date February 05, 1997
Days to Decision 399 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCH — Clip, Aneurysm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5200

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