Ear, Nose, Throat

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Code	Device name	Class	21 CFR	510(k) (3y)
BST	Curette, Biopsy, Bronchoscope (Non-Rigid)	Class 2	21 CFR 874.4680
BTG	Brush, Biopsy, Bronchoscope (Non-Rigid)	Class 2	21 CFR 874.4680	6
BWH	Forceps, Biopsy, Bronchoscope (Non-Rigid)	Class 2	21 CFR 874.4680	6
EMX	Balloon, Epistaxis	Class 1	21 CFR 874.4100	47
ENW	Catheter, Nasopharyngeal	Class 1	21 CFR 874.4175	2
ENZ	Telescope, Laryngeal-Bronchial	Class 2	21 CFR 874.4680	3
EOB	Nasopharyngoscope (Flexible Or Rigid)	Class 2	21 CFR 874.4760	162
EOQ	Bronchoscope (Flexible Or Rigid)	Class 2	21 CFR 874.4680	241
EOX	Esophagoscope (Flexible Or Rigid)	Class 2	21 CFR 874.4710	30
EPF	Hearing Aid, Group And Auditory Trainer	Class 2	21 CFR 874.3320	32
EPN	Pump, Nebulizer, Manual	Class 1	21 CFR 874.5220	2
EPP	Splint, Nasal	Class 1	21 CFR 874.5800	15
EQH	Source, Carrier, Fiberoptic Light	Class 1	21 CFR 874.4350	49
EQJ	Bur, Ear, Nose And Throat	Class 1	21 CFR 874.4140	18
EQL	Laryngostroboscope	Class 1	21 CFR 874.4750	8
EQN	Laryngoscope, Nasopharyngoscope	Class 2	21 CFR 874.4760	22
ERA	Otoscope	Class 1	21 CFR 874.4770	56
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Class 2	21 CFR 874.4250	91
ESD	Hearing Aid, Air-Conduction, Prescription	Class 1	21 CFR 874.3300	1367
ESE	Larynx, Artificial (Battery-Powered)	Class 1	21 CFR 874.3375	13
ESH	Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyuret	Class 2	21 CFR 874.3620	1
ESX	Tack, Sacculotomy (Cody Tack)	Class 2	21 CFR 874.3760	1
ESZ	Tube, Shunt, Endolymphatic	Class 2	21 CFR 874.3820	4
ETA	Replacement, Ossicular Prosthesis, Total	Class 2	21 CFR 874.3495	39
ETB	Prosthesis, Partial Ossicular Replacement	Class 2	21 CFR 874.3450	74
ETC	Mold, Middle-Ear	Class 2	21 CFR 874.3430	1
ETD	Tube, Tympanostomy	Class 2	21 CFR 874.3880	116
ETF	Unit, Examining/Treatment, Ent	Class 1	21 CFR 874.5300	32
ETK	Tube, Toynbee Diagnostic	Class 1	21 CFR 874.1925	1
ETM	Gustometer, Sterile	Class 1	21 CFR 874.1500
ETN	Stimulator, Nerve	Class 2	21 CFR 874.1820	97
ETP	Stimulator, Caloric-Water	Class 1	21 CFR 874.1800	6
ETR	Adaptor, Short Increment Sensitivity Index (Sisi)	Class 1	21 CFR 874.1070
ETS	Generator, Electronic Noise (For Audiometric Testing)	Class 2	21 CFR 874.1120	5
ETT	Cushion, Earphone (For Audiometric Testing)	Class 1	21 CFR 874.1100
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Class 2	21 CFR 874.3310	46
ETY	Tester, Auditory Impedance	Class 2	21 CFR 874.1090	70
EWA	Set, Audiometer Calibration	Class 1	21 CFR 874.1080	2
EWC	Chamber, Acoustic (For Audiometric Testing)	Class 1	21 CFR 874.1060	2
EWG	Laser, Ent Microsurgical Carbon-Dioxide	Class 2	21 CFR 874.4500	24
EWL	Prosthesis, Laryngeal (Taub)	Class 2	21 CFR 874.3730	40
EWO	Audiometer	Class 2	21 CFR 874.1050	235
EWQ	Saw, Surgical, Ent (Electric Or Pneumatic)	Class 1	21 CFR 874.4420	2
EWT	Device, Antichoke, Suction	Class 3	21 CFR 874.5350
EWW	Device, Antichoke, Tongs	Class 3	21 CFR 874.5370
EWY	Mediastinoscope, Surgical	Class 2	21 CFR 874.4720	11
FWN	Prosthesis, Larynx (Stents And Keels)	Class 2	21 CFR 874.3620	10
JAZ	Prosthesis, Facial, Mandibular Implant	Class 2	21 CFR 874.3695	2
JEI	Claw, Foreign Body, Bronchoscope (Non-Rigid)	Class 2	21 CFR 874.4680
JEJ	Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)	Class 2	21 CFR 874.4680	2
JEK	Forceps, Biopsy, Bronchoscope (Rigid)	Class 2	21 CFR 874.4680	3
JEL	Curette, Biopsy, Bronchoscope (Rigid)	Class 2	21 CFR 874.4680	1
JOF	Polymer, Ent Synthetic, Porous Polyethylene	Class 2	21 CFR 874.3620	6
JPW	Pump, Nebulizer, Electrically Powered	Class 1	21 CFR 874.5220	1
JXS	Block, Cutting, Ent, Sterile	Class 1	21 CFR 874.3540	2
JXT	Crimper, Wire, Ent, Sterile	Class 1	21 CFR 874.3540
JXW	Die, Wire Bending, Ent, Sterile	Class 1	21 CFR 874.3540
JXX	Forceps, Wire Closure, Ent, Sterile	Class 1	21 CFR 874.3540
JXY	Jig, Piston Cutting, Ent, Sterile	Class 1	21 CFR 874.3540
JXZ	Punch, Gelfoam, Sterile	Class 1	21 CFR 874.3540
JYA	Scissors, Wire Cutting, Ent, Sterile	Class 1	21 CFR 874.3540
JYB	Vise, Ossicular Finger, Sterile	Class 1	21 CFR 874.3540
JYE	Chisel, Middle-Ear	Class 1	21 CFR 874.4420	1
JYF	Clamp, Ossicle Holding	Class 1	21 CFR 874.4420
JYG	Curette, Ear	Class 1	21 CFR 874.4420	7
JYH	Excavator, Ear	Class 1	21 CFR 874.4420
JYI	Gauge, Mastoid	Class 1	21 CFR 874.4420
JYJ	Gauge, Measuring	Class 1	21 CFR 874.4420	5
JYL	Hook, Microsurgical Ear	Class 1	21 CFR 874.4420	5
JYM	Inserter, Myringotomy Tube	Class 1	21 CFR 874.4420	4
JYN	Inserter, Sacculotomy Tack	Class 1	21 CFR 874.4420
JYO	Knife, Ear	Class 1	21 CFR 874.4420	7
JYP	Knife, Myringotomy	Class 1	21 CFR 874.4420	1
JYQ	Loop, Wire	Class 1	21 CFR 874.4420	2
JYR	Nipper, Malleus	Class 1	21 CFR 874.4420	2
JYS	Perforator, Ear-Lobe	Class 1	21 CFR 874.4420	3
JYT	Pick, Microsurgical Ear	Class 1	21 CFR 874.4420	2
JYW	Press, Vein	Class 1	21 CFR 874.4420	1
JYX	Punch, Attic	Class 1	21 CFR 874.4420
JYY	Rasp, Ear	Class 1	21 CFR 874.4420	1
JYZ	Rod, Measuring Ear	Class 1	21 CFR 874.4420	1
JZA	Rongeur, Mastoid	Class 1	21 CFR 874.4420	1
JZB	Scissors, Ear	Class 1	21 CFR 874.4420	4
JZC	Searcher, Mastoid	Class 1	21 CFR 874.4420
JZD	Snare, Ear	Class 1	21 CFR 874.4420	2
JZE	Spoon, Ear	Class 1	21 CFR 874.4420	1
JZF	Tube, Ear Suction	Class 1	21 CFR 874.4420	5
JZY	Knife, Laryngeal	Class 1	21 CFR 874.4420
JZZ	Saw, Laryngeal	Class 1	21 CFR 874.4420
KAA	Set, Laryngeal Injection	Class 1	21 CFR 874.4420
KAB	Trocar, Laryngeal	Class 1	21 CFR 874.4420	1
KAC	Tube, Laryngectomy	Class 1	21 CFR 874.4420	4
KAD	Elevator, Ent	Class 1	21 CFR 874.4420	5
KAE	Forceps, Ent	Class 1	21 CFR 874.4420	14
KAH	Microrule, Ent	Class 1	21 CFR 874.4420
KAI	Mirror, Ent	Class 1	21 CFR 874.4420	9
KAJ	Mobilizer, Ent	Class 1	21 CFR 874.4420
KAK	Probe, Ent	Class 1	21 CFR 874.4420	1
KAL	Retractor, Ent	Class 1	21 CFR 874.4420	5
KAO	Curette, Ethmoid	Class 1	21 CFR 874.4420
KAP	Curette, Nasal	Class 1	21 CFR 874.4420	1
KAQ	Gouge, Nasal, Ent	Class 1	21 CFR 874.4420
KAR	Irrigator, Sinus	Class 1	21 CFR 874.4420	3
KAS	Knife, Nasal	Class 1	21 CFR 874.4420	1
KAT	Perforator, Antrum	Class 1	21 CFR 874.4420
KAW	Punch, Antrum	Class 1	21 CFR 874.4420
KAX	Punch, Ethmoid	Class 1	21 CFR 874.4420
KAY	Punch, Nasal	Class 1	21 CFR 874.4420
KAZ	Rasp, Frontal-Sinus	Class 1	21 CFR 874.4420
KBA	Rasp, Nasal	Class 1	21 CFR 874.4420
KBB	Rongeur, Nasal	Class 1	21 CFR 874.4420
KBC	Saw, Nasal	Class 1	21 CFR 874.4420	4
KBD	Scissors, Nasal	Class 1	21 CFR 874.4420	3
KBE	Snare, Nasal	Class 1	21 CFR 874.4420
KBF	Trephine, Sinus	Class 1	21 CFR 874.4420	1
KBG	Trocar, Sinus	Class 1	21 CFR 874.4420	3
KBH	Adenotome	Class 1	21 CFR 874.4420	1
KBI	Bougie, Eustachian	Class 1	21 CFR 874.4175	1
KBJ	Curette, Adenoid	Class 1	21 CFR 874.4420	1
KBK	Curette, Salpingeal	Class 1	21 CFR 874.4420
KBL	Depressor, Metal Tongue, Surgical	Class 1	21 CFR 874.4420	1
KBM	Dissector, Tonsil	Class 1	21 CFR 874.4420	1
KBN	Gag, Mouth	Class 1	21 CFR 874.4420	3
KBO	Guillotine, Tonsil	Class 1	21 CFR 874.4420	1
KBP	Hook, Tonsil Suturing	Class 1	21 CFR 874.4420
KBQ	Knife, Tonsil	Class 1	21 CFR 874.4420	1
KBR	Needle, Tonsil Suturing	Class 1	21 CFR 874.4420
KBS	Punch, Adenoid	Class 1	21 CFR 874.4420
KBT	Punch, Tonsil	Class 1	21 CFR 874.4420
KBW	Screw, Oral	Class 1	21 CFR 874.4420	1
KBX	Screw, Tonsil	Class 1	21 CFR 874.4420
KBY	Set, Filliform, Eustachian	Class 1	21 CFR 874.4175
KBZ	Snare, Tonsil	Class 1	21 CFR 874.4420	1
KCA	Tonsillectome	Class 1	21 CFR 874.4420	1
KCB	Tube, Tonsil Suction	Class 1	21 CFR 874.4420	1
KCC	Bistoury, Tracheal	Class 1	21 CFR 874.4420
KCD	Bougie, Esophageal, Ent	Class 1	21 CFR 874.4420	3
KCF	Dilator, Esophageal, Ent	Class 1	21 CFR 874.4420	3
KCG	Dilator, Tracheal	Class 1	21 CFR 874.4420	1
KCH	Hook, Tracheal	Class 1	21 CFR 874.4420
KCI	Trocar, Tracheal	Class 1	21 CFR 874.4420
KCJ	Applicator, Ent	Class 1	21 CFR 874.5220	4
KCL	Blower, Powder, Ent	Class 1	21 CFR 874.5220
KCM	Dropper, Ent	Class 1	21 CFR 874.5220	1
KCN	Ear Wick	Class 1	21 CFR 874.5220	4
KCO	Nasal Spray, Ent Delivery	Class 1	21 CFR 874.5220	1
KCP	Syringe, Ent	Class 1	21 CFR 874.5220	4
KHH	Stimulator, Caloric-Air	Class 1	21 CFR 874.1800	7
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Class 2	21 CFR 874.3620	34
KHL	Hearing Aid, Master	Class 2	21 CFR 874.3330	7
KLW	Masker, Tinnitus	Class 2	21 CFR 874.3400	78
KLX	Electroglottograph	Class 2	21 CFR 874.1325	4
KLZ	Tube, Shunt, Endolymphatic With Valve	Class 2	21 CFR 874.3850	1
KMA	Irrigator, Powered Nasal	Class 1	21 CFR 874.5550	5
KQL	Tube, Tympanostomy With Semi-Permeable Membrane	Class 2	21 CFR 874.3930
KTE	Trocar, Ent	Class 1	21 CFR 874.4420	1
KTF	Punch, Ent	Class 1	21 CFR 874.4420
KTG	Knife, Ent	Class 1	21 CFR 874.4420	5
KTH	Device, Anti-Stammering	Class 1	21 CFR 874.5840	4
KTI	Bronchoscope Accessory	Class 2	21 CFR 874.4680	34
KTR	Tube, Aspirating, Bronchoscope, Rigid	Class 2	21 CFR 874.4680	4
LBL	Tube, Tympanostomy, Porous Polyethylene	Class 2	21 CFR 874.3880	1
LBM	Porous Polyethylene Ossicular Replacement	Class 2	21 CFR 874.3450	2
LBN	Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene	Class 2	21 CFR 874.3495	1
LBP	Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material	Class 2	21 CFR 874.3450
LDG	Kit, Earmold, Impression	Class 1	21 CFR 874.3300	2
LJW	Tracheotome	Class 1	21 CFR 874.4420	2
LLO	Laser, Neodymium:Yag, Pulmonary Surgery	Class 2	21 CFR 874.4500	19
LMS	Laser, Microsurgical Argon, For Uses Other Than Otology, Including Lar	Class 2	21 CFR 874.4490	2
LRB	Face Plate Hearing Aid	Class 1	21 CFR 874.3300	24
LRC	Instrument, Ent Manual Surgical	Class 1	21 CFR 874.4420	65
LRD	Applicator, Ent Drug	Class 1	21 CFR 874.5220	6
LRE	Instrument, Prosthesis Modification For Ossicular Replacement Surgery,	Class 1	21 CFR 874.3540
LWF	Dilator, Nasal	Class 1	21 CFR 874.3900	20
LXB	Hearing Aid, Bone Conduction	Class 2	21 CFR 874.3302	53
LXR	Laser, Microsurgical Argon, For Use In Otology	Class 2	21 CFR 874.4490
LYA	Splint, Intranasal Septal	Class 1	21 CFR 874.4780	46
LYN	Apparatus, Visual Reinforcement Audiometric	Class 2	21 CFR 874.1050	3
LZI	Device, Assistive Listening	Class 2	21 CFR 874.3320	7
MAH	Hearing Aid, Bone Conduction, Implanted	Class 2	21 CFR 874.3302	12
MCK	Device, Voice Amplification	Class 2	21 CFR 874.3730
MIB	Elastomer, Silicone Block	Class 2	21 CFR 874.3620	45
MIC	Implant, Muscle, Pectoralis	Class 2	21 CFR 874.3620	8
MIX	System, Vocal Cord Medialization	Class 2	21 CFR 874.3620	17
MMO	Tray, Surgical, Ent	Class 1	21 CFR 874.4420	1
MQW	Transilluminator, Fiber Optic	Class 1	21 CFR 874.4350	1
MXP	Bone Particle Collector	Class 1	21 CFR 874.4800
NAS	Tympanometer	Class 2	21 CFR 874.1090	2
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Class 2	21 CFR 874.3620	16
NIX	Hearing Aid, Air Conduction, Transcutaneous System	Class 2	21 CFR 874.3950	2
NLB	Trocar, Tracheal, Laryngeal, Sinus, Reprocessed	Class 1	21 CFR 874.4420
NLE	Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed	Class 2	21 CFR 874.4680
NLY	Microdebrider, Ent, High Speed, Single Use, Reprocessed	Class 1	21 CFR 874.4140	1
NLZ	Bur, Ent, Diamond Coated, Single Use, Reprocessed	Class 1	21 CFR 874.4140
NNJ	Gustometer, Non-Sterile	Class 1	21 CFR 874.1500
NNN	Crimper, Wire, Ent, Non-Sterile	Class 1	21 CFR 874.3540
NNO	Jig, Piston Cutting, Ent, Non-Sterile	Class 1	21 CFR 874.3540
NNP	Die, Wire Bending, Ent, Non-Sterile	Class 1	21 CFR 874.3540
NNQ	Forceps, Wire Closure, Ent, Non-Sterile	Class 1	21 CFR 874.3540
NNR	Block, Cutting, Ent, Non-Sterile	Class 1	21 CFR 874.3540