OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE— 510(k) K853486

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K853486 for OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE, Substantially Equivalent on 1985-09-12. Applicant: Olympus Corp..

Clearance details

Applicant: Olympus Corp.
Product code: Code FGA
Advisory panel: Gastroenterology, Urology
Date received: 1985-08-20
Decision date: 1985-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGA

product code FGA

Death: 7
Total: 7

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.