Cleared Traditional

K031008 - AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)

K031008 is an FDA 510(k) clearance for AESCULAP NEURO PATTIES, manufactured by Aesculap. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K031008 · Aesculap · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
39d
Days
Class 2
Risk

K031008 is an FDA 510(k) clearance for the AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE). Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on May 9, 2003 after a review of 39 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K031008

510(k) Number K031008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 149d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HBA Neurosurgical Paddie

All 18
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K031008.
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
K062406 · Aesculap, Inc. · Sep 2006
TRAATEK COTTONOID PATTIES
K020736 · Traatek, Inc. · Jun 2002
NORAPAD PLAIN
K014268 · Perlei Medical, Inc. · Mar 2002
PACIFIC SURGICAL PATTIES
K993019 · V. Mueller Neuro/Spine · Mar 2000
K031008 · AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
Download PDF FDA Summary Aesculap