MQW · Transilluminator, Fiber Optic
Ear, Nose, Throat · 21 CFR 874.4350 · Class 1
Overview
| Product Code | MQW |
|---|---|
| Device Name | Transilluminator, Fiber Optic |
| Regulation | 21 CFR 874.4350 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962032 | KARL STORZ TWIN TRANSILLUMINATOR | KARL STORZ Endoscopy-America, Inc. | Jul 5, 1996 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 1 clearance
