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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceQ 103 NEEDLE MANAGEMENT SYSTEM
Generic NameSharps needle destruction device
Regulation Number880.6210
ApplicantQCARE INTERNATIONAL, LLC.
680 ATLANTA COUNTRY CLUB DR.
MARIETTA, GA 30067
PMA NumberP980020
Date Received05/26/1998
Decision Date12/21/2000
Reclassified Date 06/04/2018
Product Code MTV 
Docket Number 00M-1684
Notice Date 01/03/2001
Advisory Committee General Hospital
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE QCARE NEEDLE MANAGEMENT SYSTEM. THIS DEVICE IS A NEEDLE DESTRUCTION DEVICE INTENDED TO BE USED IN A HOME CARE ENVIRONMENT TO SEVER 1/2 INCH HYPODERMIC NEEDLES (GAUGES 28-29) FROM INSULIN SYRINGES AND STORE THEM FOR DISPOSAL.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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