# Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery

**Action Urgency Score:** 30/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Final rule |
| Action | Final amendment; final order. |
| Published | 2026-09-10 |
| Effective | 2026-09-10 |
| Significant | No |
| CFR parts | 21 CFR 874 |
| Summary | The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cooperative powered surgical assist device for ENT surgery. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhanc |
| Document number | 2026-18429 |

## Why this score
- Final rule.

Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/09/10/2026-18429/medical-devices-ear-nose-and-throat-devices-classification-of-the-cooperative-powered-surgical). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.