K863592

Substantially Equivalent

DISSCAP 80E, 110E, 140E, 160E

Applicant: Hospal Medical Corp.
Product code: FJI
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-15
Decision date: 1986-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Brunswick, NJ, US

Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.