FDA applicant
Genzyme Surgical Product (Genzyme Biosurgery)
FDA records 9 decisions for Genzyme Surgical Product (Genzyme Biosurgery) (Fall River, MA) from 1998 to 2000: 9 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Its devices cite 19 predicates, 1 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Genzyme Surgical Product (Genzyme Biosurgery)’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Genzyme Surgical Product (Genzyme Biosurgery) since 2007.
Recalls per year
1in 2014
Class I Class II/III not classified
Planning a device like Genzyme Surgical Product (Genzyme…’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 “Genzyme”
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