CLEARVIEW TOTAL— 510(k) K131781

Substantially Equivalent

Clinical Innovations, LLC

FDA 510(k) clearance K131781 for CLEARVIEW TOTAL, Substantially Equivalent on 2014-05-28. Applicant: Clinical Innovations, LLC.

Clearance details

Applicant: Clinical Innovations, LLC
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2013-06-17
Decision date: 2014-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murray, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.