MOUNT PLEASANT, S.C. -- Maxxon, Inc., a growing medical products designer, manufacturer, and distributor concentrating on innovative safety devices, announcea that its Maxxon/Globe Joint Venture has ordered a 5,000 piece sample batch of its functional 3cc ReVac Safety Syringe.
The 5,000 piece lot will be manufactured with Food and Drug Administration (FDA)-certified medical-grade materials. The specified materials have already been ordered and are scheduled for delivery to the manufacturing facility this week. The sample set is designed to meet FDA criteria and is scheduled for
completion within several weeks. The sample lot will be used for FDA application, as well as distributor's evaluation.
The JV plans on filing for 510k FDA application by the end of the year. In addition, the JV intends to send samples to the European Union and Japan, to seek regulatory approval in the respective jurisdictions. The approval process is projected to be several months for both regulatory bodies and will be done simultaneously.
"Several major device companies have already shown interest in the vacuum operated retractable syringe, based in part on the advantages of unique patent design and the projected lower cost," added Andy Hu, chief technical officer of Maxxon.
The new patent for the vacuum operated safety syringe was filed on Sep. 21, 2005 by patent attorney Richard Moseley. Maxxon, Inc. and Globe Medical Tech will each share 50 percent of the new patent.
The new patent covers another area of breakthrough technology. The relatively smaller cross section of the plunger, as compared to the barrel, produces a greater corresponding vacuum force to retract the used needle into the barrel. The new invention may also apply to various syringe sizes, shapes and different clinical applications. The applications in the evaluation and design phase include Vacuum Operated Retractable IV Catheter. Progress on other ReVac Safety Syringe lines include the completion of the design for 1cc, 5cc and 10cc products, as well as completed 1cc and 10cc prototypes. The functional test of both 1cc and 10cc has produced equally impressive results, by meeting the engineering criteria for generating enough vacuum force, even in the much smaller size of 1cc syringe.
Source: Maxxon, Inc.