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FDA 510(k)

OnSite Waste Sharps Container

K-Number: K182235 · 2019-05-20

ApplicantBluestone Medical, Inc.
Decision Date2019-05-20
Product CodeMMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OnSite Waste Sharps Container is the device name listed in this FDA 510(k) record. The listed applicant is Bluestone Medical, Inc.. It received FDA 510(k) clearance on 2019-05-20 under 510(k) 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. The listed applicant is Bluestone Medical, Inc.. The 510(k) number is K182235.

When did OnSite Waste Sharps Container receive FDA 510(k) clearance?

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

Who is the listed applicant for OnSite Waste Sharps Container?

The FDA 510(k) record lists Bluestone Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MMK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260845Huahong Sharps Container (HHR-I, HHR-II)Tianjin Huahong Technology Co., Ltd.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 FactoryK253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd.K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc.K252637Community Containers (Flap and Daisy)Keter Canada, Inc.K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc.

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.

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