HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS— 510(k) K931763

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K931763 for HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS, Substantially Equivalent on 1994-08-29. Applicant: Olympus Corp..

Clearance details

Applicant: Olympus Corp.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1993-04-08
Decision date: 1994-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.