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FDA 510(k)

Verifine Safety Type Insulin Pen Needle

K-Number: K210065 · 2021-04-22

Decision Date2021-04-22
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Verifine Safety Type Insulin Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K210065. 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 Verifine Safety Type Insulin Pen Needle?

Verifine Safety Type Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K210065.

When did Verifine Safety Type Insulin Pen Needle receive FDA 510(k) clearance?

Verifine Safety Type Insulin Pen Needle received FDA 510(k) clearance on 2021-04-22, under 510(k) number K210065.

Who is the listed applicant for Verifine Safety Type Insulin Pen Needle?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Verifine Safety Type Insulin Pen Needle?

The FDA product code for Verifine Safety Type Insulin Pen Needle is FMI.

Related Clinical Trials

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.

Other records listing Promisemed Hangzhou Meditech Co., Ltd. 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.

View all 35 devices →

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.