Cleared Traditional

AESCULAP AXIAL CLIP APPLIER

K984109 · Aesculap, Inc. · Neurology
Feb 1999
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K984109 is an FDA 510(k) clearance for the AESCULAP AXIAL CLIP APPLIER, a Applier, Aneurysm Clip (Class II — Special Controls, product code HCI), submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 12, 1999, 87 days after receiving the submission on November 17, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4175.

Submission Details

510(k) Number K984109 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1998
Decision Date February 12, 1999
Days to Decision 87 days
Submission Type Traditional
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

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