FDA applicant

Genzyme Biosurgery

Fall River, MA5 decisions2002–20043 recalls

FDA records 5 decisions for Genzyme Biosurgery (Fall River, MA) from 2002 to 2004: 4 510(k) clearances and 1 original PMA approval. Most are in product codes FSW (Light, Surgical, Endoscopic) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Its devices cite 5 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Genzyme Biosurgery’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genzyme Biosurgery since 2007.

Recalls per year

2in 2014

2007high 2 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Genzyme Biosurgery by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Genzyme Biosurgery’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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Other applicant names beginning “Genzyme”

FDA records each applicant name separately; these may or may not be the same firm.

Genzyme Corp. 35 Genzyme Surgical Product (Genzyme Biosurgery) 9 Genzyme Diagnostics 5 Genzyme Diagnostics P.E.I., Inc. 2

Genzyme Biosurgery

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

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Other applicant names beginning “Genzyme”