GRAFTSAVER— 510(k) K043515

Name: FDA 510(k) clearance K043515
Creator: U.S. Food and Drug Administration
Published: 2005-03-31

Substantially Equivalent

Vescare, Inc.

FDA 510(k) clearance K043515 for GRAFTSAVER, Substantially Equivalent on 2005-03-31. Applicant: Vescare, Inc.. Device class: 1.

Clearance details

Applicant: Vescare, Inc.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 2004-12-20
Decision date: 2005-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.