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FDA 510(k)

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel

K-Number: K180720 · 2018-06-27

Decision Date2018-06-27
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel is the device name listed in this FDA 510(k) record. The listed applicant is Medibio USA, LLC. It received FDA 510(k) clearance on 2018-06-27 under 510(k) number K180720. 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 Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel?

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel is a medical device that received FDA 510(k) clearance on 2018-06-27. The listed applicant is Medibio USA, LLC. The 510(k) number is K180720.

When did Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel receive FDA 510(k) clearance?

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel received FDA 510(k) clearance on 2018-06-27, under 510(k) number K180720.

Who is the listed applicant for Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel?

The FDA 510(k) record lists Medibio USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel?

The FDA product code for Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel is FMI.

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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