UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES— 510(k) K023767

Name: FDA 510(k) clearance K023767
Creator: U.S. Food and Drug Administration
Published: 2002-11-29

Substantially Equivalent

The Olympus Optical Co.

FDA 510(k) clearance K023767 for UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES, Substantially Equivalent on 2002-11-29. Applicant: The Olympus Optical Co.. Device class: 2.

Clearance details

Applicant: The Olympus Optical Co.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2002-11-12
Decision date: 2002-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES2003-01-31
K023272 — DISPOSABLE ASPIRATION NEEDLE NA-200H2002-12-23

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.