Part 874 Subpart D—Prosthetic Devices
FDA submissions for Part 874 Subpart D—Prosthetic Devices in the Ear, Nose, Throat (EN) review panel, including product codes and regulations.
Section range: §§ 874.3300–874.3950
CFR Part: 874
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| 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 | 116 |
| 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 |
