LUCINA MODEL MELODI— 510(k) K102516

Substantially Equivalent

Genadyne Biotechnologies, Inc.

FDA 510(k) clearance K102516 for LUCINA MODEL MELODI, Substantially Equivalent on 2011-08-11. Applicant: Genadyne Biotechnologies, Inc..

Clearance details

Applicant: Genadyne Biotechnologies, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2010-09-02
Decision date: 2011-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.