ETI BIPOLAR HEMOSTATIC PROBE— 510(k) K031026

Substantially Equivalent

Endo-Therapeutics, Inc.

FDA 510(k) clearance K031026 for ETI BIPOLAR HEMOSTATIC PROBE, Substantially Equivalent on 2003-06-27. Applicant: Endo-Therapeutics, Inc..

Clearance details

Applicant: Endo-Therapeutics, Inc.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2003-03-31
Decision date: 2003-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Safety Harbor, FL, US

Download summary PDF View on FDA.gov ↗

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 →

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