Cleared Traditional

YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS

K131500 · Aesculap, Inc. · Neurology
Jan 2014
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K131500 is an FDA 510(k) clearance for the YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS, a Clip, Aneurysm (Class II — Special Controls, product code HCH), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on January 24, 2014, 245 days after receiving the submission on May 24, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5200.

Submission Details

510(k) Number K131500 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2013
Decision Date January 24, 2014
Days to Decision 245 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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