Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)

K-Number: K081821 · 2008-09-02

ApplicantGlobal Pathogen Solutions, Inc.
Decision Date2008-09-02
Product CodeMMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) is the device name listed in this FDA 510(k) record. The listed applicant is Global Pathogen Solutions, Inc.. It received FDA 510(k) clearance on 2008-09-02 under 510(k) number K081821. 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 D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)?

D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) is a medical device that received FDA 510(k) clearance on 2008-09-02. The listed applicant is Global Pathogen Solutions, Inc.. The 510(k) number is K081821.

When did D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) receive FDA 510(k) clearance?

D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) received FDA 510(k) clearance on 2008-09-02, under 510(k) number K081821.

Who is the listed applicant for D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)?

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

What is the FDA product code for D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)?

The FDA product code for D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View on FDA Database →

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

↑