Rhino-Laryngo Videoscope Olympus ENF-VT3
FDA 510(k) clearance K183416 · decided 2019-09-06
Clearance details
- K-number
- K183416
- Device name
- Rhino-Laryngo Videoscope Olympus ENF-VT3
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-10
- Decision date
- 2019-09-06
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airwa recall (Z-0332-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |