VereSee Optical Veres Needle System— 510(k) K232464

Substantially Equivalent

Freyja Healthcare, LLC

FDA 510(k) clearance K232464 for VereSee Optical Veres Needle System, Substantially Equivalent on 2024-05-02. Applicant: Freyja Healthcare, LLC.

Clearance details

Applicant: Freyja Healthcare, LLC
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2023-08-15
Decision date: 2024-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.