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 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