HBA · Class II · 21 CFR 882.4700

FDA Product Code HBA: Neurosurgical Paddie

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

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 Sep 15, 2006
AESCULAP NEURO PATTIES
K062406
Aesculap, Inc.
Neurology · 29d
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 Mar 02, 1988
CODMAN SURGICAL PATTIE
K880402
Codman & Shurtleff, Inc.
Neurology · 33d

About Product Code HBA - Regulatory Context