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FDA 510(k)

FiXcision

K-Number: K182664 · 2018-12-07

ApplicantAgency For Medical Innovations GmbH
Decision Date2018-12-07
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FiXcision 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 2018-12-07 under 510(k) number K182664. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FiXcision?

FiXcision is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Agency For Medical Innovations GmbH. The 510(k) number is K182664.

When did FiXcision receive FDA 510(k) clearance?

FiXcision received FDA 510(k) clearance on 2018-12-07, under 510(k) number K182664.

Who is the listed applicant for FiXcision?

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 FiXcision?

The FDA product code for FiXcision is KOA.

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.

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Official Source

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

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