HAE · Class II · 21 CFR 882.4840

FDA Product Code HAE: Rongeur, Manual

Leading manufacturers include Baxano, Inc., Morpheus AG and Integra Lifesciences Corp..

37
Total
37
Cleared
158d
Avg days
1988
Since
37 devices
25–37 of 37
Cleared Mar 07, 2007
ULTRA LOW PROFILE RONGEUR
K062711
Baxano, Inc.
Neurology · 177d
Cleared Feb 07, 2003
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
K023868
Dannoritzer Medical Instruments
Neurology · 79d
Cleared Dec 06, 1995
BRAY RONGEUR
K954699
Johnson & Johnson Professionals, Inc.
Neurology · 55d
Cleared Feb 21, 1995
KERRISON RONGEURS
K943583
Enterprise Medical Corp.
Neurology · 214d
Cleared Dec 07, 1994
ULTRA-LINE RONGEUR
K943635
V. Mueller Neuro/Spine
Neurology · 133d
Cleared Jul 27, 1994
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116
United States Surgical, A Division of Tyco Healthc
Neurology · 30d
Cleared Jan 12, 1994
NEDBOND EJECTOR KERRISON RONGEUR
K933978
Redmond Neurotechnologies Corp.
Neurology · 149d
Cleared Dec 11, 1990
INTERVERTEBRAL DISC RONGEUR
K903151
Von Zeppelin GmbH
Neurology · 146d
Cleared Aug 10, 1990
SPECIAL RONGEUR
K903401
Sur-Med Instruments, Inc.
Neurology · 10d
Cleared Jul 23, 1990
INSTRUMENTS FOR NEUROLOGICAL SURGERY
K901313
Von Zeppelin GmbH
Neurology · 125d
Cleared Jun 28, 1990
LAMINECTOMY RONGEUR
K901372
Zeppelin GmbH
Neurology · 98d
Cleared May 11, 1989
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K892535
Zinnanti Surgical Instruments, Inc.
Neurology · 30d
Cleared Jan 22, 1988
RONGEUR (NEUROSURGICAL INSTRUMENTS)
K875043
Solway, Inc.
Neurology · 51d