OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES— 510(k) K942338

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K942338 for OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES, Substantially Equivalent on 1994-11-30. Applicant: Olympus Corp..

Clearance details

Applicant: Olympus Corp.
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 1994-05-16
Decision date: 1994-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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Adverse events under product code FDT

product code FDT

Death: 86
Injury: 1,954
Malfunction: 14,912
Total: 16,952

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.