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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 a medical device manufactured by Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-10-25 under approval 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. It is manufactured by Owen Mumford, Ltd.. The 510(k) number is K222303.

When was Unistik® Pro approved by the FDA?

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

What company makes Unistik® Pro?

Unistik® Pro is manufactured by Owen Mumford, Ltd..

What is the FDA product code for Unistik® Pro?

The FDA product code for Unistik® Pro is FMK.

Other Devices by Owen Mumford, Ltd.

K152339Unifine Pentips/ Unifine Pentips Plus K173881Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G K210399Unifine SafeControl K222168Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler K221613Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets K222111Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G

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Related Devices (Code: FMK)

K153670Genteel Lancing DeviceGenteel, LLC K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsBecton, Dickinson and Company

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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