510(k) K223144 ยท EOQ Bronchoscope (Flexible Or Rigid)
Galaxy System
| Applicant | Noah Medical Corp., San Carlos CA, US |
| Decision | Substantially Equivalent, Mar 1, 2023 |
| Received | Oct 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | Noah Medical Corporation Brand Name: Galaxy System
Product Name: Galaxy System
Model/Catalog Number: GAL-001
Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of Open, Classified |
EOQ | None listed |
| Dec 20, 2024 | Noah Medical Galaxy System (GAL-001).
Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. Open, Classified |
EOQ | None listed |
| Dec 18, 2024 | Noah Medical Galaxy System (GAL-001) Open, Classified |
EOQ | None listed |
| Dec 13, 2024 | Noah Medical Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001) Open, Classified |
EOQ | None listed |
| May 1, 2024 | Noah Medical Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller)
The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagn Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.