QJL · Splint, Intranasal Septal, Cber Led
Ear, Nose, Throat · 21 CFR 874.4780 · Class 1
Overview
| Product Code | QJL |
|---|---|
| Device Name | Splint, Intranasal Septal, Cber Led |
| Regulation | 21 CFR 874.4780 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160101 | SinuBand | Bioinspire Technologies, Incorporated | Jul 27, 2016 | SESE |
Top Applicants
- Bioinspire Technologies, Incorporated — 1 clearance
