KSEA BIPOLAR ELECTROTOME— 510(k) K061541

Substantially Equivalent

Ksea

FDA 510(k) clearance K061541 for KSEA BIPOLAR ELECTROTOME, Substantially Equivalent on 2006-08-21. Applicant: Ksea.

Clearance details

Applicant: Ksea
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2006-06-05
Decision date: 2006-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, 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.