FRANZEN NEEDLE GUIDE— 510(k) K830235

Substantially Equivalent

Precision Dynamics Corp.

FDA 510(k) clearance K830235 for FRANZEN NEEDLE GUIDE, Substantially Equivalent on 1983-02-23. Applicant: Precision Dynamics Corp..

Clearance details

Applicant: Precision Dynamics Corp.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1983-01-25
Decision date: 1983-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.