CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM— 510(k) K882105

Unknown

Dianon Systems, Inc.

FDA 510(k) clearance K882105 for CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM, Unknown on 1988-07-11. Applicant: Dianon Systems, Inc..

Clearance details

Applicant: Dianon Systems, Inc.
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 1988-05-19
Decision date: 1988-07-11
Decision: Unknown
Clearance type: Traditional
Location: Stratford, CT, US

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.