FDA 510(k)

MEDOJECT fine Pen Needles

K-Number: K220614 · 2022-06-15

Decision Date2022-06-15

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDOJECT fine Pen Needles is a medical device manufactured by Chirana T. Injecta. It received FDA 510(k) clearance on 2022-06-15 under approval number K220614. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDOJECT fine Pen Needles?

MEDOJECT fine Pen Needles is a medical device that received FDA 510(k) clearance on 2022-06-15. It is manufactured by Chirana T. Injecta. The 510(k) number is K220614.

When was MEDOJECT fine Pen Needles approved by the FDA?

MEDOJECT fine Pen Needles received FDA 510(k) clearance on 2022-06-15, under approval number K220614.

What company makes MEDOJECT fine Pen Needles?

MEDOJECT fine Pen Needles is manufactured by Chirana T. Injecta.

What is the FDA product code for MEDOJECT fine Pen Needles?

The FDA product code for MEDOJECT fine Pen Needles is FMI.

Other Devices by Chirana T. Injecta

K201009CHIRAVAC Blood Collection Needles K201044CHIRANA Insulin Syringes K242434Insulin Syringes

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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.