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., Xomed, Inc. and KARL STORZ Endoscopy-America, Inc..

91
Total
91
Cleared
100d
Avg days
1978
Since
91 devices
49–72 of 91
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 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
Cleared Aug 15, 1986
TREACE DRILL SYSTEM
K862807
Treace Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Jan 21, 1986
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Aug 12, 1982
TORX OR TYPE MICRO MOTOR HANDPIECE
K822008
Kelleher Corp.
Ear, Nose, Throat · 35d
Cleared Nov 27, 1979
FISCH DRILL SYSTEM
K792159
Jedmed Instrument Co.
Ear, Nose, Throat · 29d
Cleared Aug 22, 1979
WOMED NICRO-CRAFT POWER SYSTEM
K791407
Xomed, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 31, 1978
XOMED TRANSSPHENOIDAL HANDPIECE
K781418
Xomed, Inc.
Ear, Nose, Throat · 15d