Acessa ProVu System— 510(k) K181124

Substantially Equivalent

Acessa Health, Inc.

FDA 510(k) clearance K181124 for Acessa ProVu System, Substantially Equivalent on 2018-09-28. Applicant: Acessa Health, Inc..

Clearance details

Applicant: Acessa Health, Inc.
Product code: Code HFG
Advisory panel: Obstetrics/Gynecology
Date received: 2018-04-30
Decision date: 2018-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HFG

product code HFG

Death: 3
Injury: 121
Total: 124

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.