Cleared Traditional

AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)

K031008 · Aesculap · Neurology
May 2003
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K031008 is an FDA 510(k) clearance for the AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE), a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on May 9, 2003, 39 days after receiving the submission on March 31, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4700.

Submission Details

510(k) Number K031008 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2003
Decision Date May 09, 2003
Days to Decision 39 days
Submission Type Traditional
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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