ENDO-NEEDLE INSTRUMENT— 510(k) K936207

Substantially Equivalent

Gerard Medical, Inc.

FDA 510(k) clearance K936207 for ENDO-NEEDLE INSTRUMENT, Substantially Equivalent on 1994-06-16. Applicant: Gerard Medical, Inc..

Clearance details

Applicant: Gerard Medical, Inc.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1993-12-29
Decision date: 1994-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlton, MA, 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.