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FDA 510(k)

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

K-Number: K251874 · 2025-10-14

ApplicantPureway Compliance, Inc.
Decision Date2025-10-14
Product CodeMMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is a medical device manufactured by Pureway Compliance, Inc.. It received FDA 510(k) clearance on 2025-10-14 under approval number K251874. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)?

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is a medical device that received FDA 510(k) clearance on 2025-10-14. It is manufactured by Pureway Compliance, Inc.. The 510(k) number is K251874.

When was PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) approved by the FDA?

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) received FDA 510(k) clearance on 2025-10-14, under approval number K251874.

What company makes PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)?

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is manufactured by Pureway Compliance, Inc..

What is the FDA product code for PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)?

The FDA product code for PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is MMK.

Other Devices by Pureway Compliance, Inc.

K231484PureWay 1.4 Quart Sharps Collector

Related Devices (Code: MMK)

K153274Med-Tainer Single Deposit ContainerSnyder Industries, Inc. K153363Red2Green Reusable Sharps ContainerTriumvirate Environmental, Inc. K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC K152340NAR Sharps Shuttle; NAR Sharps Shuttle Pack of sixNorth American Rescue, LLC K170513MAUSER PG II Sharps ContainerMauzer USA, LLC K172719HealthBeacon HB2 Sharps BinHealthbeacon, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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