Airway Mobilescope
FDA 510(k) clearance K201300 · decided 2021-01-26
Clearance details
- K-number
- K201300
- Device name
- Airway Mobilescope
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-15
- Decision date
- 2021-01-26
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- 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 |
|---|---|---|
| Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endob recall (Z-0340-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. recall (Z-2499-2023) | Olympus Corporation of the Americas | 2023-08-31 |