ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)— 510(k) K800416

Substantially Equivalent

A.D.T. Lab Industries

FDA 510(k) clearance K800416 for ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA), Substantially Equivalent on 1980-03-25. Applicant: A.D.T. Lab Industries.

Clearance details

Applicant: A.D.T. Lab Industries
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1980-02-26
Decision date: 1980-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.