Decision Date2017-11-01
Product CodeMMK
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
MAUSER PG II Sharps Container is the device name listed in this FDA 510(k) record. The listed applicant is Mauzer USA, LLC. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K170513. 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 MAUSER PG II Sharps Container?
MAUSER PG II Sharps Container is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Mauzer USA, LLC. The 510(k) number is K170513.
When did MAUSER PG II Sharps Container receive FDA 510(k) clearance?
MAUSER PG II Sharps Container received FDA 510(k) clearance on 2017-11-01, under 510(k) number K170513.
Who is the listed applicant for MAUSER PG II Sharps Container?
The FDA 510(k) record lists Mauzer USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MAUSER PG II Sharps Container?
The FDA product code for MAUSER PG II Sharps Container is MMK.
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.K252637Community Containers (Flap and Daisy)Keter Canada, Inc.K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc.K231484PureWay 1.4 Quart Sharps CollectorPureway Compliance, Inc.
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.