21 CFR 874.4780 — Splint, Intranasal Septal
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4780
Identification
An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LYA | Splint, Intranasal Septal | 1 | 46 | |
| QJL | Splint, Intranasal Septal, Cber Led | 1 | 1 |
