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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 With An Integral Sharps Injury Prevention Feature
510(k) Number K233796
Device Name Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
Applicant
SteriLance Medical (Suzhou), Inc.
#168 Putuoshan Rd.
New District
Suzhou,  CN 215153
Applicant Contact Susan Sun
Correspondent
SteriLance Medical (Suzhou), Inc.
#168 Putuoshan Rd.
New District
Suzhou,  CN 215153
Correspondent Contact Susan Sun
Regulation Number878.4850
Classification Product Code
FMK  
Date Received11/29/2023
Decision Date 01/16/2024
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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