Elegant Advanced CompHort— 510(k) K231794

Substantially Equivalent

Viramal Limited

FDA 510(k) clearance K231794 for Elegant Advanced CompHort, Substantially Equivalent on 2023-12-22. Applicant: Viramal Limited.

Clearance details

Applicant: Viramal Limited
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2023-06-20
Decision date: 2023-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

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.