Cleared Special

AESCULAP NEURO PATTIES

K062406 · Aesculap, Inc. · Neurology
Sep 2006
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K062406 is an FDA 510(k) clearance for the AESCULAP NEURO PATTIES, a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 15, 2006, 29 days after receiving the submission on August 17, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4700.

Submission Details

510(k) Number K062406 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2006
Decision Date September 15, 2006
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBA — Neurosurgical Paddie
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4700

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