Transit-Pellets
K-Number: K181760 · 2019-08-08
ApplicantMedifactia AB
Decision Date2019-08-08
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Transit-Pellets is a medical device manufactured by Medifactia AB. It received FDA 510(k) clearance on 2019-08-08 under approval number K181760. 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 2019-08-08. It is manufactured by Medifactia AB. The 510(k) number is K181760.
When was Transit-Pellets approved by the FDA?
Transit-Pellets received FDA 510(k) clearance on 2019-08-08, under approval number K181760.
What company makes Transit-Pellets?
Transit-Pellets is manufactured by Medifactia AB.
What is the FDA product code for Transit-Pellets?
The FDA product code for Transit-Pellets is FFX.
Other Devices by Medifactia AB
Related Devices (Code: FFX)
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.