MEDSURG ULTRASOUND BIOPSY TRAY— 510(k) K854289

Substantially Equivalent

Medsurg Industries, Inc.

FDA 510(k) clearance K854289 for MEDSURG ULTRASOUND BIOPSY TRAY, Substantially Equivalent on 1985-11-26. Applicant: Medsurg Industries, Inc..

Clearance details

Applicant: Medsurg Industries, Inc.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1985-10-25
Decision date: 1985-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herndon, VA, US

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Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.