FDA 510(k)

OnSite Waste Sharps Container

K-Number: K182235 · 2019-05-20

Decision Date2019-05-20

Product CodeMMK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

OnSite Waste Sharps Container is a medical device manufactured by Bluestone Medical, Inc.. It received FDA 510(k) clearance on 2019-05-20 under approval number K182235. 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 OnSite Waste Sharps Container?

OnSite Waste Sharps Container is a medical device that received FDA 510(k) clearance on 2019-05-20. It is manufactured by Bluestone Medical, Inc.. The 510(k) number is K182235.

When was OnSite Waste Sharps Container approved by the FDA?

OnSite Waste Sharps Container received FDA 510(k) clearance on 2019-05-20, under approval number K182235.

What company makes OnSite Waste Sharps Container?

OnSite Waste Sharps Container is manufactured by Bluestone Medical, Inc..

What is the FDA product code for OnSite Waste Sharps Container?

The FDA product code for OnSite Waste Sharps Container is MMK.

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

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