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)
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.

View all Aesculap, Inc. devices

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
119d faster than avg
Panel avg: 148d · 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 11
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K062406.
MEDLINE NEURO SPONGE
K140369 · Medline Industries, Inc. · Sep 2014
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598 · American Surgical Company, LLC · Jun 2013
DELICOT
K121822 · American Surgical Company, LLC · Sep 2012
PACIFIC SURGICAL PATTIES
K993019 · V. Mueller Neuro/Spine · Mar 2000
ULTRACELL NEURO SPONGES
K973083 · Ultracell Medical Technologies, Inc. · Dec 1997
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
K962807 · American Surgical Sponges · May 1997