BREAST LOCALIZATION NEEDLES— 510(k) K881730

Substantially Equivalent

Hart Enterprises, Inc.

FDA 510(k) clearance K881730 for BREAST LOCALIZATION NEEDLES, Substantially Equivalent on 1988-05-13. Applicant: Hart Enterprises, Inc..

Clearance details

Applicant: Hart Enterprises, Inc.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1988-04-22
Decision date: 1988-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wyoming, MI, 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.