SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX— 510(k) K994328

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K994328 for SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX, Substantially Equivalent on 2000-03-02. Applicant: Genzyme Corp.. Device class: 2.

Clearance details

Applicant: Genzyme Corp.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1999-12-22
Decision date: 2000-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.