EndoCure Model EUR078A— 510(k) K161147

Substantially Equivalent

Endocure Technologies, Inc.

FDA 510(k) clearance K161147 for EndoCure Model EUR078A, Substantially Equivalent on 2016-06-07. Applicant: Endocure Technologies, Inc..

Clearance details

Applicant: Endocure Technologies, Inc.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 2016-04-22
Decision date: 2016-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beltsville, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.