Ear, Nose, Throat (EN) FDA Submissions
Browse FDA 510(k), De Novo, and PMA medical device clearances for the Ear, Nose, Throat (EN) review panel, including product codes, regulations, and cleared devices.
CFR Parts: Part 868, Part 874, Part 892
Subparts
- Part 868 Subpart C—Monitoring Devices — 1 product code
- Part 874 Subpart B—Diagnostic Devices — 21 product codes
- Part 874 Subpart D—Prosthetic Devices — 64 product codes
- Part 874 Subpart E—Surgical Devices — 129 product codes
- Part 874 Subpart F—Therapeutic Devices — 18 product codes
- Part 874 Subpart G — 2 product codes
- Part 892 Subpart B—Diagnostic Devices — 1 product code
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QRS | Device For Sleep Apnea Testing Based On Mandibular Movement | 868.2376 | 2 | 3 |
| EWO | Audiometer | 874.1050 | 2 | 235 |
| LYN | Apparatus, Visual Reinforcement Audiometric | 874.1050 | 2 | 3 |
| EWC | Chamber, Acoustic (For Audiometric Testing) | 874.1060 | 1 | 2 |
| ETR | Adaptor, Short Increment Sensitivity Index (Sisi) | 874.1070 | 1 | 0 |
| EWA | Set, Audiometer Calibration | 874.1080 | 1 | 2 |
| ETY | Tester, Auditory Impedance | 874.1090 | 2 | 70 |
| NAS | Tympanometer | 874.1090 | 2 | 2 |
| PTO | Tester, Auditory Impedance, Exempt | 874.1090 | 2 | 0 |
| PTP | Tympanometer, Exempt | 874.1090 | 2 | 0 |
| ETT | Cushion, Earphone (For Audiometric Testing) | 874.1100 | 1 | 0 |
| ETS | Generator, Electronic Noise (For Audiometric Testing) | 874.1120 | 2 | 5 |
| KLX | Electroglottograph | 874.1325 | 2 | 4 |
| ETM | Gustometer, Sterile | 874.1500 | 1 | 0 |
| NNJ | Gustometer, Non-Sterile | 874.1500 | 1 | 0 |
| NRK | Kit, Test, Olfactory | 874.1600 | 2 | 1 |
| ETP | Stimulator, Caloric-Water | 874.1800 | 1 | 6 |
| KHH | Stimulator, Caloric-Air | 874.1800 | 1 | 7 |
| ETN | Stimulator, Nerve | 874.1820 | 2 | 97 |
| PDQ | Neurosurgical Nerve Locator | 874.1820 | 2 | 34 |
| QWP | Optical Neurosurgical Nerve Locator | 874.1820 | 2 | 1 |
| ETK | Tube, Toynbee Diagnostic | 874.1925 | 1 | 1 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 874.3300 | 1 | 1367 |
| LDG | Kit, Earmold, Impression | 874.3300 | 1 | 2 |
| LRB | Face Plate Hearing Aid | 874.3300 | 1 | 24 |
| QUF | Hearing Aid, Air-Conduction, Over The Counter | 874.3300 | 1 | 0 |
| LXB | Hearing Aid, Bone Conduction | 874.3302 | 2 | 49 |
| MAH | Hearing Aid, Bone Conduction, Implanted | 874.3302 | 2 | 11 |
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription | 874.3305 | 2 | 1 |
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | 874.3305 | 2 | 0 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 874.3310 | 2 | 46 |
| PLK | Tympanic Membrane Direct Contact Hearing Aid | 874.3315 | 2 | 3 |
| EPF | Hearing Aid, Group And Auditory Trainer | 874.3320 | 2 | 32 |
| LZI | Device, Assistive Listening | 874.3320 | 2 | 7 |
| QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription | 874.3325 | 2 | 7 |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | 874.3325 | 2 | 9 |
| KHL | Hearing Aid, Master | 874.3330 | 2 | 7 |
| SCR | Air-Conduction Hearing Aid Software | 874.3335 | 2 | 3 |
| PFO | Active Implantable Bone Conduction Hearing System | 874.3340 | 2 | 11 |
| ESE | Larynx, Artificial (Battery-Powered) | 874.3375 | 1 | 13 |
| KLW | Masker, Tinnitus | 874.3400 | 2 | 76 |
| QVN | Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus | 874.3410 | 2 | 1 |
| ETC | Mold, Middle-Ear | 874.3430 | 2 | 1 |
| ETB | Prosthesis, Partial Ossicular Replacement | 874.3450 | 2 | 74 |
| LBM | Porous Polyethylene Ossicular Replacement | 874.3450 | 2 | 2 |
| LBP | Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material | 874.3450 | 2 | 0 |
| ETA | Replacement, Ossicular Prosthesis, Total | 874.3495 | 2 | 39 |
| LBN | Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene | 874.3495 | 2 | 1 |
| JXS | Block, Cutting, Ent, Sterile | 874.3540 | 1 | 2 |
| JXT | Crimper, Wire, Ent, Sterile | 874.3540 | 1 | 0 |
| JXW | Die, Wire Bending, Ent, Sterile | 874.3540 | 1 | 0 |
| JXX | Forceps, Wire Closure, Ent, Sterile | 874.3540 | 1 | 0 |
| JXY | Jig, Piston Cutting, Ent, Sterile | 874.3540 | 1 | 0 |
| JXZ | Punch, Gelfoam, Sterile | 874.3540 | 1 | 0 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | 874.3540 | 1 | 0 |
| JYB | Vise, Ossicular Finger, Sterile | 874.3540 | 1 | 0 |
| LRE | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile | 874.3540 | 1 | 0 |
| NNN | Crimper, Wire, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNO | Jig, Piston Cutting, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNP | Die, Wire Bending, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNQ | Forceps, Wire Closure, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNR | Block, Cutting, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNS | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile | 874.3540 | 1 | 0 |
| NNT | Punch, Gelfoam, Non-Sterile | 874.3540 | 1 | 0 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNV | Vise, Ossicular Finger, Non-Sterile | 874.3540 | 1 | 0 |
| ESH | Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane | 874.3620 | 2 | 1 |
| FWN | Prosthesis, Larynx (Stents And Keels) | 874.3620 | 2 | 10 |
| JOF | Polymer, Ent Synthetic, Porous Polyethylene | 874.3620 | 2 | 6 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 874.3620 | 2 | 33 |
| MIB | Elastomer, Silicone Block | 874.3620 | 2 | 45 |
| MIC | Implant, Muscle, Pectoralis | 874.3620 | 2 | 8 |
| MIX | System, Vocal Cord Medialization | 874.3620 | 2 | 17 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 874.3620 | 2 | 15 |
| JAZ | Prosthesis, Facial, Mandibular Implant | 874.3695 | 2 | 2 |
| EWL | Prosthesis, Laryngeal (Taub) | 874.3730 | 2 | 40 |
| MCK | Device, Voice Amplification | 874.3730 | 2 | 0 |
| ESX | Tack, Sacculotomy (Cody Tack) | 874.3760 | 2 | 1 |
| ESZ | Tube, Shunt, Endolymphatic | 874.3820 | 2 | 4 |
| KLZ | Tube, Shunt, Endolymphatic With Valve | 874.3850 | 2 | 1 |
| ETD | Tube, Tympanostomy | 874.3880 | 2 | 115 |
| LBL | Tube, Tympanostomy, Porous Polyethylene | 874.3880 | 2 | 1 |
| OGS | Myringotomy Procedure Kit | 874.3880 | 2 | 0 |
| LWF | Dilator, Nasal | 874.3900 | 1 | 20 |
| KQL | Tube, Tympanostomy With Semi-Permeable Membrane | 874.3930 | 2 | 0 |
| NIX | Hearing Aid, Air Conduction, Transcutaneous System | 874.3950 | 2 | 2 |
| EMX | Balloon, Epistaxis | 874.4100 | 1 | 47 |
| EQJ | Bur, Ear, Nose And Throat | 874.4140 | 1 | 18 |
| NLY | Microdebrider, Ent, High Speed, Single Use, Reprocessed | 874.4140 | 1 | 1 |
| NLZ | Bur, Ent, Diamond Coated, Single Use, Reprocessed | 874.4140 | 1 | 0 |
| ENW | Catheter, Nasopharyngeal | 874.4175 | 1 | 2 |
| KBI | Bougie, Eustachian | 874.4175 | 1 | 1 |
| KBY | Set, Filliform, Eustachian | 874.4175 | 1 | 0 |
| PNZ | Eustachian Tube Balloon Dilation Device | 874.4180 | 2 | 9 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 874.4250 | 2 | 91 |
| EQH | Source, Carrier, Fiberoptic Light | 874.4350 | 1 | 49 |
| MQW | Transilluminator, Fiber Optic | 874.4350 | 1 | 1 |
| EWQ | Saw, Surgical, Ent (Electric Or Pneumatic) | 874.4420 | 1 | 2 |
| JYE | Chisel, Middle-Ear | 874.4420 | 1 | 1 |
| JYF | Clamp, Ossicle Holding | 874.4420 | 1 | 0 |
| JYG | Curette, Ear | 874.4420 | 1 | 7 |
| JYH | Excavator, Ear | 874.4420 | 1 | 0 |
| JYI | Gauge, Mastoid | 874.4420 | 1 | 0 |
| JYJ | Gauge, Measuring | 874.4420 | 1 | 5 |
| JYL | Hook, Microsurgical Ear | 874.4420 | 1 | 5 |
| JYM | Inserter, Myringotomy Tube | 874.4420 | 1 | 4 |
| JYN | Inserter, Sacculotomy Tack | 874.4420 | 1 | 0 |
| JYO | Knife, Ear | 874.4420 | 1 | 7 |
| JYP | Knife, Myringotomy | 874.4420 | 1 | 1 |
| JYQ | Loop, Wire | 874.4420 | 1 | 2 |
| JYR | Nipper, Malleus | 874.4420 | 1 | 2 |
| JYS | Perforator, Ear-Lobe | 874.4420 | 1 | 3 |
| JYT | Pick, Microsurgical Ear | 874.4420 | 1 | 2 |
| JYW | Press, Vein | 874.4420 | 1 | 1 |
| JYX | Punch, Attic | 874.4420 | 1 | 0 |
| JYY | Rasp, Ear | 874.4420 | 1 | 1 |
| JYZ | Rod, Measuring Ear | 874.4420 | 1 | 1 |
| JZA | Rongeur, Mastoid | 874.4420 | 1 | 1 |
| JZB | Scissors, Ear | 874.4420 | 1 | 4 |
| JZC | Searcher, Mastoid | 874.4420 | 1 | 0 |
| JZD | Snare, Ear | 874.4420 | 1 | 2 |
| JZE | Spoon, Ear | 874.4420 | 1 | 1 |
| JZF | Tube, Ear Suction | 874.4420 | 1 | 5 |
| JZY | Knife, Laryngeal | 874.4420 | 1 | 0 |
| JZZ | Saw, Laryngeal | 874.4420 | 1 | 0 |
| KAA | Set, Laryngeal Injection | 874.4420 | 1 | 0 |
| KAB | Trocar, Laryngeal | 874.4420 | 1 | 1 |
| KAC | Tube, Laryngectomy | 874.4420 | 1 | 4 |
| KAD | Elevator, Ent | 874.4420 | 1 | 5 |
| KAE | Forceps, Ent | 874.4420 | 1 | 14 |
| KAH | Microrule, Ent | 874.4420 | 1 | 0 |
| KAI | Mirror, Ent | 874.4420 | 1 | 9 |
| KAJ | Mobilizer, Ent | 874.4420 | 1 | 0 |
| KAK | Probe, Ent | 874.4420 | 1 | 1 |
| KAL | Retractor, Ent | 874.4420 | 1 | 5 |
| KAO | Curette, Ethmoid | 874.4420 | 1 | 0 |
| KAP | Curette, Nasal | 874.4420 | 1 | 1 |
| KAQ | Gouge, Nasal, Ent | 874.4420 | 1 | 0 |
| KAR | Irrigator, Sinus | 874.4420 | 1 | 3 |
| KAS | Knife, Nasal | 874.4420 | 1 | 1 |
| KAT | Perforator, Antrum | 874.4420 | 1 | 0 |
| KAW | Punch, Antrum | 874.4420 | 1 | 0 |
| KAX | Punch, Ethmoid | 874.4420 | 1 | 0 |
| KAY | Punch, Nasal | 874.4420 | 1 | 0 |
| KAZ | Rasp, Frontal-Sinus | 874.4420 | 1 | 0 |
| KBA | Rasp, Nasal | 874.4420 | 1 | 0 |
| KBB | Rongeur, Nasal | 874.4420 | 1 | 0 |
| KBC | Saw, Nasal | 874.4420 | 1 | 4 |
| KBD | Scissors, Nasal | 874.4420 | 1 | 3 |
| KBE | Snare, Nasal | 874.4420 | 1 | 0 |
| KBF | Trephine, Sinus | 874.4420 | 1 | 1 |
| KBG | Trocar, Sinus | 874.4420 | 1 | 3 |
| KBH | Adenotome | 874.4420 | 1 | 1 |
| KBJ | Curette, Adenoid | 874.4420 | 1 | 1 |
| KBK | Curette, Salpingeal | 874.4420 | 1 | 0 |
| KBL | Depressor, Metal Tongue, Surgical | 874.4420 | 1 | 1 |
| KBM | Dissector, Tonsil | 874.4420 | 1 | 1 |
| KBN | Gag, Mouth | 874.4420 | 1 | 3 |
| KBO | Guillotine, Tonsil | 874.4420 | 1 | 1 |
| KBP | Hook, Tonsil Suturing | 874.4420 | 1 | 0 |
| KBQ | Knife, Tonsil | 874.4420 | 1 | 1 |
| KBR | Needle, Tonsil Suturing | 874.4420 | 1 | 0 |
| KBS | Punch, Adenoid | 874.4420 | 1 | 0 |
| KBT | Punch, Tonsil | 874.4420 | 1 | 0 |
| KBW | Screw, Oral | 874.4420 | 1 | 1 |
| KBX | Screw, Tonsil | 874.4420 | 1 | 0 |
| KBZ | Snare, Tonsil | 874.4420 | 1 | 1 |
| KCA | Tonsillectome | 874.4420 | 1 | 1 |
| KCB | Tube, Tonsil Suction | 874.4420 | 1 | 1 |
| KCC | Bistoury, Tracheal | 874.4420 | 1 | 0 |
| KCD | Bougie, Esophageal, Ent | 874.4420 | 1 | 3 |
| KCF | Dilator, Esophageal, Ent | 874.4420 | 1 | 3 |
| KCG | Dilator, Tracheal | 874.4420 | 1 | 1 |
| KCH | Hook, Tracheal | 874.4420 | 1 | 0 |
| KCI | Trocar, Tracheal | 874.4420 | 1 | 0 |
| KTE | Trocar, Ent | 874.4420 | 1 | 1 |
| KTF | Punch, Ent | 874.4420 | 1 | 0 |
| KTG | Knife, Ent | 874.4420 | 1 | 5 |
| LJW | Tracheotome | 874.4420 | 1 | 2 |
| LRC | Instrument, Ent Manual Surgical | 874.4420 | 1 | 65 |
| MMO | Tray, Surgical, Ent | 874.4420 | 1 | 1 |
| NLB | Trocar, Tracheal, Laryngeal, Sinus, Reprocessed | 874.4420 | 1 | 0 |
| OGR | Ear, Nose, And Throat Surgical Tray | 874.4420 | 1 | 0 |
| OGU | Pierced Ear/Entry Cleaning Tray | 874.4420 | 1 | 0 |
| QGK | Balloon, Nasal Airway | 874.4420 | 1 | 1 |
| SBS | Laryngeal Injection Set With Led Light | 874.4420 | 1 | 1 |
| QQH | Powered Insertion System For A Cochlear Implant Electrode Array | 874.4450 | 2 | 2 |
| QXG | Cooperative Powered Surgical Assist Device For Ent Surgery | 874.4460 | 2 | 1 |
| LMS | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology | 874.4490 | 2 | 2 |
| LXR | Laser, Microsurgical Argon, For Use In Otology | 874.4490 | 2 | 0 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 874.4500 | 2 | 24 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 874.4500 | 2 | 19 |
| BST | Curette, Biopsy, Bronchoscope (Non-Rigid) | 874.4680 | 2 | 0 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | 874.4680 | 2 | 6 |
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | 874.4680 | 2 | 6 |
| ENZ | Telescope, Laryngeal-Bronchial | 874.4680 | 2 | 3 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 874.4680 | 2 | 236 |
| JEI | Claw, Foreign Body, Bronchoscope (Non-Rigid) | 874.4680 | 2 | 0 |
| JEJ | Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating) | 874.4680 | 2 | 2 |
| JEK | Forceps, Biopsy, Bronchoscope (Rigid) | 874.4680 | 2 | 3 |
| JEL | Curette, Biopsy, Bronchoscope (Rigid) | 874.4680 | 2 | 1 |
| KTI | Bronchoscope Accessory | 874.4680 | 2 | 33 |
| KTR | Tube, Aspirating, Bronchoscope, Rigid | 874.4680 | 2 | 4 |
| NLE | Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed | 874.4680 | 2 | 0 |
| QNW | Reprocessed Bronchoscope | 874.4680 | 2 | 2 |
| EOX | Esophagoscope (Flexible Or Rigid) | 874.4710 | 2 | 30 |
| EWY | Mediastinoscope, Surgical | 874.4720 | 2 | 11 |
| EQL | Laryngostroboscope | 874.4750 | 1 | 8 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 874.4760 | 2 | 160 |
| EQN | Laryngoscope, Nasopharyngoscope | 874.4760 | 2 | 21 |
| ERA | Otoscope | 874.4770 | 1 | 56 |
| SHL | Ear, Nose, And Throat Image Analyzer | 874.4775 | 2 | 1 |
| LYA | Splint, Intranasal Septal | 874.4780 | 1 | 46 |
| QJL | Splint, Intranasal Septal, Cber Led | 874.4780 | 1 | 1 |
| MXP | Bone Particle Collector | 874.4800 | 1 | 0 |
| EPN | Pump, Nebulizer, Manual | 874.5220 | 1 | 2 |
| JPW | Pump, Nebulizer, Electrically Powered | 874.5220 | 1 | 1 |
| KCJ | Applicator, Ent | 874.5220 | 1 | 4 |
| KCL | Blower, Powder, Ent | 874.5220 | 1 | 0 |
| KCM | Dropper, Ent | 874.5220 | 1 | 1 |
| KCN | Ear Wick | 874.5220 | 1 | 4 |
| KCO | Nasal Spray, Ent Delivery | 874.5220 | 1 | 1 |
| KCP | Syringe, Ent | 874.5220 | 1 | 4 |
| LRD | Applicator, Ent Drug | 874.5220 | 1 | 6 |
| ETF | Unit, Examining/Treatment, Ent | 874.5300 | 1 | 32 |
| EWT | Device, Antichoke, Suction | 874.5350 | 3 | 0 |
| EWW | Device, Antichoke, Tongs | 874.5370 | 3 | 0 |
| QXN | Suction Anti-Choking Device As A Second-Line Treatment | 874.5400 | 2 | 1 |
| KMA | Irrigator, Powered Nasal | 874.5550 | 1 | 5 |
| EPP | Splint, Nasal | 874.5800 | 1 | 15 |
| KTH | Device, Anti-Stammering | 874.5840 | 1 | 4 |
| PKA | External Upper Esophageal Sphincter (Ues) Compression Device | 874.5900 | 2 | 2 |
| QQG | Oropharyngeal Electrical Stimulator | 874.5950 | 2 | 1 |
| QNU | Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion | 874.6000 | 2 | 1 |
| QZC | External Mechanical Stimulator For The Relief Of Congestion | 874.6010 | 2 | 2 |
| QQE | Image Management Software For Planning Of Otologic And Neurotologic Procedures | 892.2050 | 2 | 3 |
