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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 the device name listed in this FDA 510(k) record. The listed applicant is Chirana T. Injecta. It received FDA 510(k) clearance on 2022-06-15 under 510(k) 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. The listed applicant is Chirana T. Injecta. The 510(k) number is K220614.

When did MEDOJECT fine Pen Needles receive FDA 510(k) clearance?

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

Who is the listed applicant for MEDOJECT fine Pen Needles?

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

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

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

Other records listing Chirana T. Injecta 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: FMI)

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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