MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL— 510(k) K854420

Name: FDA 510(k) clearance K854420
Creator: U.S. Food and Drug Administration
Published: 1985-11-22

Substantially Equivalent

Meadox Surgimed, Inc.

FDA 510(k) clearance K854420 for MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL, Substantially Equivalent on 1985-11-22. Applicant: Meadox Surgimed, Inc.. Device class: 1.

Clearance details

Applicant: Meadox Surgimed, Inc.
Product code: Code GDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-11-04
Decision date: 1985-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.