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FDA 510(k)

Disposable Insulin Pen Needle

K-Number: K221178 · 2022-11-17

Decision Date2022-11-17
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Insulin Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K221178. 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 Disposable Insulin Pen Needle?

Disposable Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K221178.

When did Disposable Insulin Pen Needle receive FDA 510(k) clearance?

Disposable Insulin Pen Needle received FDA 510(k) clearance on 2022-11-17, under 510(k) number K221178.

Who is the listed applicant for Disposable Insulin Pen Needle?

The FDA 510(k) record lists Ningbo Medsun Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Insulin Pen Needle?

The FDA product code for Disposable Insulin Pen Needle is FMI.

Other records listing Ningbo Medsun Medical 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 7 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.