FDA applicant
Sterile Concepts, Inc.
FDA records 10 decisions for Sterile Concepts, Inc. (Richmond, VA) from 1992 to 1995: 10 510(k) clearances. Most are in product codes LRO (General Surgery Tray) and FRG (Wrap, Sterilization). 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 Sterile Concepts, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sterile Concepts, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sterile Concepts, Inc.’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) ReportOther applicant names beginning “Sterile”
FDA records each applicant name separately; these may or may not be the same firm.