YAG LASER 8000 GASTROINTESTINAL BLEE— 510(k) K840144

Substantially Equivalent

Cooper Medical Corp.

FDA 510(k) clearance K840144 for YAG LASER 8000 GASTROINTESTINAL BLEE, Substantially Equivalent on 1984-05-18. Applicant: Cooper Medical Corp..

Clearance details

Applicant: Cooper Medical Corp.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1984-01-13
Decision date: 1984-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.