FNA THYROID BIOPSY KIT— 510(k) K870863

Substantially Equivalent

Flint Laboratories Div. Travenol

FDA 510(k) clearance K870863 for FNA THYROID BIOPSY KIT, Substantially Equivalent on 1987-05-08. Applicant: Flint Laboratories Div. Travenol.

Clearance details

Applicant: Flint Laboratories Div. Travenol
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1987-03-03
Decision date: 1987-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shreveport, LA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.