Cleared Traditional

Aesculap Slim Clip Applier

K211572 · Aesculap, Inc. · Neurology
Dec 2021
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K211572 is an FDA 510(k) clearance for the Aesculap Slim Clip Applier, a Applier, Aneurysm Clip (Class II — Special Controls, product code HCI), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 13, 2021, 206 days after receiving the submission on May 21, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4175.

Submission Details

510(k) Number K211572 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2021
Decision Date December 13, 2021
Days to Decision 206 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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