FDA 510(k) Applications for Medical Device Product Code "HBA"
(Neurosurgical Paddie)

FDA 510(k) Number Applicant Device Name Decision Date
K031008 AESCULAP AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) 05/09/2003
K062406 AESCULAP, INC. AESCULAP NEURO PATTIES 09/15/2006
K112598 AMERICAN SURGICAL COMPANY, LLC AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) 06/20/2013
K121822 AMERICAN SURGICAL COMPANY, LLC DELICOT 09/10/2012
K962807 AMERICAN SURGICAL SPONGES AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES 05/02/1997
K073576 HAROD ENTERPRISES, INC. NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES 02/22/2008
K193346 Integra LifeSciences Corporation Codman Surgical Patties & Strips 11/20/2020
K140369 MEDLINE INDUSTRIES, INC. MEDLINE NEURO SPONGE 09/26/2014
K014268 PERLEI MEDICAL, INC. NORAPAD PLAIN; NORAPAD TA 03/27/2002
K020736 TRAATEK, INC. TRAATEK COTTONOID PATTIES 06/03/2002
K973083 ULTRACELL MEDICAL TECHNOLOGIES, INC. ULTRACELL NEURO SPONGES 12/09/1997
K970328 ULTRACELL MEDICAL TECHNOLOGIES, INC. ULTRACELL NEURO SPONGES 04/21/1997
K993019 V. MUELLER NEURO/SPINE PACIFIC SURGICAL PATTIES 03/30/2000


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