FDA applicant
Celestray Biotech Company, LLC.,
FDA records 2 decisions for Celestray Biotech Company, LLC., (Bethesda, MD) from 2023 to 2024: 2 510(k) clearances. Most are in product codes JXI (Cuff, Nerve) and OWW (Mesh, Surgical, Absorbable, Orthopaedics…). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Celestray Biotech Company, LLC.,’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Celestray Biotech Company, LLC.,’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report