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HBA — Neurosurgical Paddie Class II

FDA Device Classification

FDA product code HBA covers "Neurosurgical Paddie", a Class II medical device regulated under 21 CFR 882.4700. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HBA
Device Class
Class II
Regulation Number
882.4700
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K193346integra lifesciences corporationCodman Surgical Patties & StripsNovember 20, 2020
K140369medline industriesMEDLINE NEURO SPONGESeptember 26, 2014
K112598american surgical companyAMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)June 20, 2013
K121822american surgical companyDELICOTSeptember 10, 2012
K073576harod enterprisesNEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGESFebruary 22, 2008
K062406aesculapAESCULAP NEURO PATTIESSeptember 15, 2006
K031008aesculapAESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)May 9, 2003
K020736traatekTRAATEK COTTONOID PATTIESJune 3, 2002
K014268perlei medicalNORAPAD PLAIN; NORAPAD TAMarch 27, 2002
K993019v. mueller neuro/spinePACIFIC SURGICAL PATTIESMarch 30, 2000
K973083ultracell medical technologiesULTRACELL NEURO SPONGESDecember 9, 1997
K962807american surgical spongesAMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGESMay 2, 1997
K970328ultracell medical technologiesULTRACELL NEURO SPONGESApril 21, 1997
K950647ultracell medical technologiesULTRACELL NEURO SPONGESAugust 15, 1995
K914600i mNEUROLOGICAL SPONGEDecember 30, 1992
K923027martland healthcareNEURAY SURGICAL PATTIES AND STRIPSAugust 28, 1992
K904514american silk suturesSTRUNG TELFA NON-ADHERENT SPONGEMarch 27, 1991
K902921american silk suturesRAYON NEUROLOGICAL SPONGESeptember 18, 1990
K891993vitaphoreCOLLAGEN NEUROSPONGEMarch 23, 1990
K880402codman and shurtleffCODMAN SURGICAL PATTIEMarch 2, 1988

FDA data resources