Part 874 Subpart F—Therapeutic Devices
FDA submissions for Part 874 Subpart F—Therapeutic Devices in the Ear, Nose, Throat (EN) review panel, including product codes and regulations.
Section range: §§ 874.5220–874.5950
CFR Part: 874
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| 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 |