FDA applicant
Acra Cut, Inc.
FDA records 8 decisions for Acra Cut, Inc. (Acton, MA) from 1983 to 2003: 8 510(k) clearances. Most are in product codes HBF (Drills, Burrs, Trephines & Accessories…) and HBE (Drills, Burrs, Trephines & Accessories…). 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 Acra Cut, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Acra Cut, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Acra Cut, 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) Report