EW-10 AND EW-20— 510(k) K915402

Substantially Equivalent for Some Indications

Olympus Corp.

FDA 510(k) clearance K915402 for EW-10 AND EW-20, Substantially Equivalent for Some Indications on 1995-06-23. Applicant: Olympus Corp..

Clearance details

Applicant: Olympus Corp.
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 1991-12-04
Decision date: 1995-06-23
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.