Part 874 Subpart G
FDA submissions for Part 874 Subpart G in the Ear, Nose, Throat (EN) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 874.6000–874.6010
CFR Part: 874
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| 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 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K242214 | Sonu | Sound Health Systems, Inc. | Apr 24, 2025 |
| DEN230045 | Sonu | Sound Health Systems, Inc. | Dec 4, 2023 |
| DEN200006 | ClearUP Sinus Relief | Tivic Health Systems, Inc. | Mar 5, 2021 |
