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FDA 510(k)

Unistik® Pro

K-Number: K222303 · 2022-10-25

ApplicantOwen Mumford, Ltd.
Decision Date2022-10-25
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Unistik® Pro is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-10-25 under 510(k) number K222303. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unistik® Pro?

Unistik® Pro is a medical device that received FDA 510(k) clearance on 2022-10-25. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K222303.

When did Unistik® Pro receive FDA 510(k) clearance?

Unistik® Pro received FDA 510(k) clearance on 2022-10-25, under 510(k) number K222303.

Who is the listed applicant for Unistik® Pro?

The FDA 510(k) record lists Owen Mumford, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unistik® Pro?

The FDA product code for Unistik® Pro is FMK.

Other records listing Owen Mumford, 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.

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Related Devices (Code: FMK)

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.

K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.

Official Source

View on FDA Database →

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

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