PeriCALM Patterns 3.0— 510(k) K241009

Substantially Equivalent

Perigen, Inc.

FDA 510(k) clearance K241009 for PeriCALM Patterns 3.0, Substantially Equivalent on 2025-01-10. Applicant: Perigen, Inc..

Clearance details

Applicant: Perigen, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2024-04-12
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rishon Letziyon, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.