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FDA 510(k)

PeriCALM Patterns 3.0

K-Number: K241009 · 2025-01-10

ApplicantPerigen, Inc.
Decision Date2025-01-10
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PeriCALM Patterns 3.0 is a medical device manufactured by Perigen, Inc.. It received FDA 510(k) clearance on 2025-01-10 under approval number K241009. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PeriCALM Patterns 3.0?

PeriCALM Patterns 3.0 is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Perigen, Inc.. The 510(k) number is K241009.

When was PeriCALM Patterns 3.0 approved by the FDA?

PeriCALM Patterns 3.0 received FDA 510(k) clearance on 2025-01-10, under approval number K241009.

What company makes PeriCALM Patterns 3.0?

PeriCALM Patterns 3.0 is manufactured by Perigen, Inc..

What is the FDA product code for PeriCALM Patterns 3.0?

The FDA product code for PeriCALM Patterns 3.0 is HGM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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