Cleared Special

K062406 - AESCULAP NEURO PATTIES

K062406 is an FDA 510(k) clearance for AESCULAP NEURO PATTIES, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HBA cleared through the Special 510(k) pathway after a 29-day FDA review.

K062406 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
29d
Days
Class 2
Risk

K062406 is an FDA 510(k) clearance for the AESCULAP NEURO PATTIES. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 15, 2006 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062406

510(k) Number K062406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

HBA Device Classification - Class 2, Special Controls

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBA Neurosurgical Paddie

All 23
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K062406.
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598 · American Surgical Company, LLC · Jun 2013
DELICOT
K121822 · American Surgical Company, LLC · Sep 2012
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
K073576 · Harod Enterprises, Inc. · Feb 2008
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
K031008 · Aesculap · May 2003
TRAATEK COTTONOID PATTIES
K020736 · Traatek, Inc. · Jun 2002
NORAPAD PLAIN
K014268 · Perlei Medical, Inc. · Mar 2002
K062406 · AESCULAP NEURO PATTIES
Download PDF FDA Summary Aesculap, Inc.