HBA · Class II · 21 CFR 882.4700

FDA Product Code HBA: Neurosurgical Paddie

Leading manufacturers include American Silk Sutures, Inc., Ultracell Medical Technologies, Inc. and American Surgical Company, LLC.

24
Total
24
Cleared
168d
Avg days
1977
Since

FDA 510(k) Cleared Neurosurgical Paddie Devices (Product Code HBA)

24 devices
1–24 of 24
Cleared Nov 20, 2020
Codman Surgical Patties & Strips
K193346
Integra LifeSciences Corporation
Neurology · 353d
Cleared Sep 26, 2014
MEDLINE NEURO SPONGE
K140369
Medline Industries, Inc.
Neurology · 224d
Cleared Jun 20, 2013
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598
American Surgical Company, LLC
Neurology · 652d
Cleared Sep 10, 2012
DELICOT
K121822
American Surgical Company, LLC
Neurology · 81d
Cleared Feb 22, 2008
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
K073576
Harod Enterprises, Inc.
Neurology · 65d
Cleared Sep 15, 2006
AESCULAP NEURO PATTIES
K062406
Aesculap, Inc.
Neurology · 29d
Cleared May 09, 2003
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
K031008
Aesculap
Neurology · 39d
Cleared Jun 03, 2002
TRAATEK COTTONOID PATTIES
K020736
Traatek, Inc.
Neurology · 89d
Cleared Mar 27, 2002
NORAPAD PLAIN
K014268
Perlei Medical, Inc.
Neurology · 90d
Cleared Mar 30, 2000
PACIFIC SURGICAL PATTIES
K993019
V. Mueller Neuro/Spine
Neurology · 204d
Cleared Dec 09, 1997
ULTRACELL NEURO SPONGES
K973083
Ultracell Medical Technologies, Inc.
Neurology · 113d
Cleared May 02, 1997
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
K962807
American Surgical Sponges
Neurology · 288d
Cleared Apr 21, 1997
ULTRACELL NEURO SPONGES
K970328
Ultracell Medical Technologies, Inc.
Neurology · 84d
Cleared Aug 15, 1995
ULTRACELL NEURO SPONGES
K950647
Ultracell Medical Technologies, Inc.
Neurology · 183d
Cleared Dec 30, 1992
NEUROLOGICAL SPONGE
K914600
I M, Inc.
Neurology · 446d
Cleared Aug 28, 1992
NEURAY SURGICAL PATTIES AND STRIPS
K923027
Martland Healthcare, Inc.
Neurology · 66d
Cleared Mar 27, 1991
STRUNG TELFA NON-ADHERENT SPONGE
K904514
American Silk Sutures, Inc.
Neurology · 176d
Cleared Sep 18, 1990
RAYON NEUROLOGICAL SPONGE
K902921
American Silk Sutures, Inc.
Neurology · 77d
Cleared Mar 23, 1990
COLLAGEN NEUROSPONGE
K891993
Vitaphore Corp.
Neurology · 360d
Cleared Mar 02, 1988
CODMAN SURGICAL PATTIE
K880402
Codman & Shurtleff, Inc.
Neurology · 33d
Cleared Jul 30, 1986
POLYESTER SPONGE PATTIE
K862494
American Silk Sutures, Inc.
Neurology · 29d
Cleared Mar 20, 1986
COTTON NEUROLOGICAL SPONGE
K854713
American Silk Sutures, Inc.
Neurology · 118d
Cleared Jun 13, 1985
NEURO CUSTOM SURGICAL KIT
K844594
Xanmed Corp.
Neurology · 199d
Cleared Jun 20, 1977
NEURO-SORB PATTIES
K770894
Instranetics, Inc.
Neurology · 35d

About Product Code HBA - Regulatory Context