SIF-SW— 510(k) K904800

Name: FDA 510(k) clearance K904800
Creator: U.S. Food and Drug Administration
Published: 1991-03-27

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K904800 for SIF-SW, Substantially Equivalent on 1991-03-27. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code FDA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1990-10-24
Decision date: 1991-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.