K950247

Substantially Equivalent

TS 564/PF

Applicant: Bressler, Amery & Ross
Product code: FJK
Advisory panel: Gastroenterology, Urology
Date received: 1995-01-20
Decision date: 1995-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.