MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY— 510(k) K854262

Substantially Equivalent

Meadox Surgimed, Inc.

FDA 510(k) clearance K854262 for MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY, Substantially Equivalent on 1985-12-24. Applicant: Meadox Surgimed, Inc..

Clearance details

Applicant: Meadox Surgimed, Inc.
Product code: Code FZX
Advisory panel: General, Plastic Surgery
Date received: 1985-10-23
Decision date: 1985-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

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Adverse events under product code FZX

product code FZX

Injury: 797
Malfunction: 3,815
Total: 4,612

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.