Cleared Traditional

K073576 - NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES

K073576 is an FDA 510(k) clearance for NEUROSURGICAL SPONGES AND PADDLES AND N..., manufactured by Harod Enterprises, Inc.. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K073576 · Harod Enterprises, Inc. · Neurology device
Download Printable Device Report (PDF)
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Feb 2008
Decision
65d
Days
Class 2
Risk

K073576 is an FDA 510(k) clearance for the NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by Harod Enterprises, Inc. (Martinez, US). The FDA issued a Cleared decision on February 22, 2008 after a review of 65 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.

View all Harod Enterprises, Inc. devices

FDA 510(k) Submission Details - K073576

510(k) Number K073576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2007
Decision Date February 22, 2008
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 148d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 9
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K073576.
Codman Surgical Patties & Strips
K193346 · Integra LifeSciences Corporation · Nov 2020
MEDLINE NEURO SPONGE
K140369 · Medline Industries, Inc. · Sep 2014
AESCULAP NEURO PATTIES
K062406 · Aesculap, Inc. · Sep 2006
PACIFIC SURGICAL PATTIES
K993019 · V. Mueller Neuro/Spine · Mar 2000
ULTRACELL NEURO SPONGES
K973083 · Ultracell Medical Technologies, Inc. · Dec 1997
ULTRACELL NEURO SPONGES
K970328 · Ultracell Medical Technologies, Inc. · Apr 1997