MERIT BIPOLAR COAGULATION PROBE— 510(k) K102273

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K102273 for MERIT BIPOLAR COAGULATION PROBE, Substantially Equivalent on 2010-09-07. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2010-08-11
Decision date: 2010-09-07
Decision: Substantially Equivalent
Clearance type: Special
Location: South Jordan, UT, 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.