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FDA 510(k)

More-Cell-System

K-Number: K212659 · 2021-11-10

Decision Date2021-11-10
Product CodePMU
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

More-Cell-System is the device name listed in this FDA 510(k) record. The listed applicant is Agency For Medical Innovations GmbH. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212659. The device is classified under product code PMU. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the More-Cell-System?

More-Cell-System is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Agency For Medical Innovations GmbH. The 510(k) number is K212659.

When did More-Cell-System receive FDA 510(k) clearance?

More-Cell-System received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212659.

Who is the listed applicant for More-Cell-System?

The FDA 510(k) record lists Agency For Medical Innovations GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for More-Cell-System?

The FDA product code for More-Cell-System is PMU.

Other records listing Agency For Medical Innovations GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: PMU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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