OLYMPUS LUS ULTRASONIC LITHOTRIPTER— 510(k) K873367

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K873367 for OLYMPUS LUS ULTRASONIC LITHOTRIPTER, Substantially Equivalent on 1987-11-30. Applicant: Olympus Corp..

Clearance details

Applicant: Olympus Corp.
Product code: Code FEO
Advisory panel: Gastroenterology, Urology
Date received: 1987-08-21
Decision date: 1987-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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Adverse events under product code FEO

product code FEO

Malfunction: 910
Other: 1
Total: 911

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.