FINE NEEDLE ASPIRATION DEVICE— 510(k) K841275

Substantially Equivalent

Gyneco, Inc.

FDA 510(k) clearance K841275 for FINE NEEDLE ASPIRATION DEVICE, Substantially Equivalent on 1984-08-17. Applicant: Gyneco, Inc..

Clearance details

Applicant: Gyneco, Inc.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 1984-03-27
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

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.