Disposable Safety Lancet

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

SteriLance Medical (Suzhou) Inc.

The following data is part of a premarket notification filed by Sterilance Medical (suzhou) Inc. with the FDA for Disposable Safety Lancet.

Pre-market Notification Details

Device IDK221521
510k NumberK221521
Device Name:Disposable Safety Lancet
ClassificationSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Applicant SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District, Suzhou,  CN 215153
ContactSusan Sun
CorrespondentSusan Sun
SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District, Suzhou,  CN 215153
Product CodeFMK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-25
Decision Date2022-10-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
36945630114862 K221521 000
36945630114855 K221521 000

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