FDA 510(k)

Transit-Pellets

K-Number: K222000 · 2023-01-18

Decision Date2023-01-18

Product CodeFFX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Transit-Pellets is the device name listed in this FDA 510(k) record. The listed applicant is Medifactia AB. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K222000. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transit-Pellets?

Transit-Pellets is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Medifactia AB. The 510(k) number is K222000.

When did Transit-Pellets receive FDA 510(k) clearance?

Transit-Pellets received FDA 510(k) clearance on 2023-01-18, under 510(k) number K222000.

Who is the listed applicant for Transit-Pellets?

The FDA 510(k) record lists Medifactia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transit-Pellets?

The FDA product code for Transit-Pellets is FFX.

Other records listing Medifactia AB 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.

K181760Transit-Pellets

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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.