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., Stryker Corporation and Xomed, Inc..

91
Total
91
Cleared
100d
Avg days
1978
Since
91 devices
49–72 of 91
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 Mar 10, 1998
ULTRABUR
K974174
Mednet Locator, Inc.
Ear, Nose, Throat · 124d
Cleared Nov 05, 1997
POWERTREK INSTRUMENTS
K972057
Medtrek Corp.
Ear, Nose, Throat · 156d
Cleared Oct 01, 1997
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584
Stryker Endoscopy
Ear, Nose, Throat · 83d
Cleared Sep 29, 1997
PROMEX ENT TISSUE REMOVAL SYSTEM
K972865
Promex, Inc.
Ear, Nose, Throat · 56d
Cleared Sep 29, 1997
ENT IRRIGATING PUMP (70327700)
K973286
Gyrus Ent LLC
Ear, Nose, Throat · 27d
Cleared Sep 05, 1997
XPS STRAIGHTSHOT MICRORESECTOR
K972453
Xomed, Inc.
Ear, Nose, Throat · 67d
Cleared Apr 09, 1997
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
K970965
Midas Rex Pneumatic Tools, Inc.
Ear, Nose, Throat · 23d
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 Sep 23, 1996
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
K963246
Medtronic Xomed
Ear, Nose, Throat · 35d
Cleared Jul 25, 1996
MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
K962163
Misten Medical Corp.
Ear, Nose, Throat · 51d
Cleared Apr 26, 1996
IRRIGATION SYSTEM
K961192
Linvatec Corp.
Ear, Nose, Throat · 31d
Cleared Nov 27, 1995
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K954989
Smith & Nephew Dyonics, Inc.
Ear, Nose, Throat · 27d
Cleared Nov 06, 1995
MICRO-INGRESSOR HANDIPIECE
K954796
Trebay Medical Corp.
Ear, Nose, Throat · 19d
Cleared Oct 27, 1995
MICRO-PLANER HANDPIECE
K954715
Trebay Medical Corp.
Ear, Nose, Throat · 15d
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 Jan 09, 1995
BLACKSTAR(TM) STAR SYSTEM
K945659
Xomed-Treace, Inc.
Ear, Nose, Throat · 53d
Cleared Nov 22, 1994
ELECTRIC SURGICAL DRILL
K940016
Alamo City Dental Supply Co.
Ear, Nose, Throat · 322d