FDA applicant
Acufex Microsurgical, Inc.
FDA records 78 decisions for Acufex Microsurgical, Inc. (Mansfield, MA) from 1980 to 1996: 78 510(k) clearances. Most are in product codes HRX (Arthroscope) and JDR (Staple, Fixation, Bone). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Acufex Microsurgical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Acufex Microsurgical, Inc. since 2007.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Acufex Microsurgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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