OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2— 510(k) K041494

Name: FDA 510(k) clearance K041494
Creator: U.S. Food and Drug Administration
Published: 2004-07-01

Substantially Equivalent

Olympus Corporation

FDA 510(k) clearance K041494 for OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2, Substantially Equivalent on 2004-07-01. Applicant: Olympus Corporation. Device class: 2.

Clearance details

Applicant: Olympus Corporation
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2004-06-04
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.