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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
510(k) Number K222617
Device Name EasyTouch Lancing Device
Applicant
Stat Medical Devices
2056 NE 153rd St.
North Miami Beach,  FL  33162
Applicant Contact Hemel Mariano
Correspondent
FDA Compliance Group
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.4850
Classification Product Code
QRK  
Subsequent Product Code
QRL  
Date Received08/30/2022
Decision Date 03/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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