SYMPHONY GRAFT DELIVERY SYSTEM (GDS)— 510(k) K012738

Name: FDA 510(k) clearance K012738
Creator: U.S. Food and Drug Administration
Published: 2001-11-14

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K012738 for SYMPHONY GRAFT DELIVERY SYSTEM (GDS), Substantially Equivalent on 2001-11-14. Applicant: Depuyacromed. Device class: 1.

Clearance details

Applicant: Depuyacromed
Product code: Code GEY
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 2001-08-16
Decision date: 2001-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.