ERL · Class II · 21 CFR 874.4250

FDA Product Code ERL: Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

Leading manufacturers include Medtronic Xomed, Inc., Linvatec Corp. and Stryker Corporation.

91
Total
91
Cleared
100d
Avg days
1978
Since
91 devices
25–48 of 91
Cleared Jul 23, 2004
XPS 3000 SYSTEM
K041523
Medtronic Xomed, Inc.
Ear, Nose, Throat · 45d
Cleared Jul 12, 2004
XPS 3000 SYSTEM
K041413
Medtronic Xomed, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 03, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300
Stryker Instruments
Ear, Nose, Throat · 23d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321
Medtronic Xomed, Inc.
Ear, Nose, Throat · 60d
Cleared May 25, 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381
Stryker Instruments
Ear, Nose, Throat · 18d
Cleared Apr 13, 2001
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 108d
Cleared Oct 17, 2000
XPS NITRO SYSTEM
K002828
Xomed, Inc.
Ear, Nose, Throat · 36d
Cleared Feb 19, 1999
HUMMER TRAK SYSTEM
K990038
Stryker Endoscopy
Ear, Nose, Throat · 44d
Cleared Nov 25, 1998
PNEUMATIC CUTTER SYSTEM
K983050
Surgical Laser Technologies, Inc.
Ear, Nose, Throat · 85d
Cleared Oct 21, 1998
XPS DRILL SYSTEM
K983224
Xomed, Inc.
Ear, Nose, Throat · 37d
Cleared Aug 27, 1998
SLT BIPOLAR SHEATH
K981041
Surgical Laser Technologies, Inc.
Ear, Nose, Throat · 160d
Cleared Jul 20, 1998
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K981637
Linvatec Corp.
Ear, Nose, Throat · 73d
Cleared Oct 01, 1997
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584
Stryker Endoscopy
Ear, Nose, Throat · 83d
Cleared Sep 05, 1997
XPS STRAIGHTSHOT MICRORESECTOR
K972453
Xomed, Inc.
Ear, Nose, Throat · 67d
Cleared Jan 17, 1997
APEX UNIVERSAL DRIVE SYSTEM
K964548
Linvatec Corp.
Ear, Nose, Throat · 65d
Cleared Jan 10, 1997
ANSPACH MICROMAX SYSTEM
K965080
The Anspach Effort, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 26, 1996
IRRIGATION SYSTEM
K961192
Linvatec Corp.
Ear, Nose, Throat · 31d
Cleared Jul 20, 1995
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K952681
Stryker Endoscopy
Ear, Nose, Throat · 38d
Cleared Apr 17, 1995
INTRAARC DRIVE SYSTEM
K951263
Linvatec Corp.
Ear, Nose, Throat · 27d
Cleared Mar 24, 1995
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 09, 1995
STRYKER TOTAL PERFORMANCE SYSTEM
K943569
Stryker Corp.
Ear, Nose, Throat · 171d
Cleared Nov 18, 1994
APEX UNIVERSAL DRIVE SYSTEM
K944476
Linvatec Corp.
Ear, Nose, Throat · 67d
Cleared May 16, 1994
STRYKER MICRODEBRIDER SYSTEM
K940710
Stryker Corp.
Ear, Nose, Throat · 88d
Cleared Sep 04, 1987
TREACE MAGNUM OTO-TOOL SYSTEM
K873154
Treace Medical, Inc.
Ear, Nose, Throat · 24d