IOPSY TRAY FOR SOFT TISSUE BIOPSY— 510(k) K771784

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K771784 for IOPSY TRAY FOR SOFT TISSUE BIOPSY, Substantially Equivalent on 1977-11-30. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 1977-09-23
Decision date: 1977-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.