Galaxy System
FDA 510(k) clearance K223144 · decided 2023-03-01
Clearance details
- K-number
- K223144
- Device name
- Galaxy System
- Applicant
- Noah Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2022-10-04
- Decision date
- 2023-03-01
- Days to decision
- 148 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
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Produc recall (Z-0598-2026) | Noah Medical Corporation | 2025-11-26 |
| Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to recall (Z-0742-2025) | Noah Medical | 2024-12-20 |
| Galaxy System (GAL-001) recall (Z-0693-2025) | Noah Medical | 2024-12-18 |
| Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, par recall (Z-0679-2025) | Noah Medical | 2024-12-13 |
| Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and i recall (Z-1734-2024) | Noah Medical | 2024-05-01 |