FDA.reportPublic FDA data

510(k) K251874

Device
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
Applicant
Pureway Compliance, Inc.
510(k) number
K251874
Product code
MMK
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-14
Date received
2025-06-18
Regulation
880.5570
Classification name
Container, Sharps
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jeffrey Miglicco
Address
2717 Commercial Center Blvd. Cinco Rancy Suite 200 Katy TX US 77494 77494

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MMK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); GuanhongTaizhou Huangyan Guanhong Plastic Steel Products Factory2026-05-22
K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd.2025-12-22
K252637Community Containers (Flap and Daisy)Keter Canada, Inc.2025-10-14
K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc.2023-09-14
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K211890Promisemed Sharps containerPromisemed Hangzhou Meditech Co., Ltd.2021-11-17
K211464Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd.2021-09-14
K203305Tiger Reusable Sharps ContainerInternational Marketing Specialists, Inc.2021-08-06
K201523Sharps containerZhejiang Gongdong Medical Technology Co., Ltd.2020-11-12
K190240Tiger Sharps ContainersInternational Marketing Specialists, Inc.2019-05-31
K182235OnSite Waste Sharps ContainerBluestone Medical, Inc.2019-05-20
K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd.2019-01-03
K180983Maxcon Two Gallon Chemotherapy ContainerNingbo Maxcon Medical Technology Co., Ltd.2019-01-03