HAWKINS BREAST LOCALIZATION NEEDLE— 510(k) K870523

Substantially Equivalent

N-S Medical Products

FDA 510(k) clearance K870523 for HAWKINS BREAST LOCALIZATION NEEDLE, Substantially Equivalent on 1987-03-09. Applicant: N-S Medical Products.

Clearance details

Applicant: N-S Medical Products
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1987-02-06
Decision date: 1987-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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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.