USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE— 510(k) K973820

Substantially Equivalent

Circon Corp.

FDA 510(k) clearance K973820 for USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE, Substantially Equivalent on 1998-05-12. Applicant: Circon Corp..

Clearance details

Applicant: Circon Corp.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1997-10-07
Decision date: 1998-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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.