T-TUBE INSERTER
Device Facts
| Record ID | K831590 |
|---|---|
| Device Name | T-TUBE INSERTER |
| Applicant | Treace Medical, Inc. |
| Product Code | EQH · Ear, Nose, Throat |
| Decision Date | Jun 15, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4350 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.
