XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT— 510(k) K030194

Name: FDA 510(k) clearance K030194
Creator: U.S. Food and Drug Administration
Published: 2003-03-24

Substantially Equivalent

The Olympus Optical Co.

FDA 510(k) clearance K030194 for XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT, Substantially Equivalent on 2003-03-24. Applicant: The Olympus Optical Co.. Device class: 2.

Clearance details

Applicant: The Olympus Optical Co.
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2003-01-21
Decision date: 2003-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNS

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More clearances from The Olympus Optical Co.

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K032066 — SONOSURG SYSTEM2003-10-03
K021962 — OLYMPUS ULTRASONIC SURGICAL SYSTEM2003-02-12
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
K023767 — UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES2002-11-29

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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 →

Recalls naming K030194

K-number listed on FDA's recall record

Z-1277-2013 — Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.Class II·Terminated·Olympus America Inc.·20091110

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030194.

Data sourced from openFDA. This site is unofficial and independent of the FDA.