FDA applicant
Andrews Surgical Innovations, Ltd.
FDA records 1 decision for Andrews Surgical Innovations, Ltd. (Co. Dublin, IE) in 2002: 1 510(k) clearance. All are in product code MDM (Instrument, Manual, Surgical, General Use). 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 Andrews Surgical Innovations, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Andrews Surgical Innovations, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Andrews Surgical Innovations, Ltd.’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