Home » FDA Clears Vanguard Reprocessed Ultrasonic Scalpels
FDA Clears Vanguard Reprocessed Ultrasonic Scalpels
March 30, 2005
The FDA has determined that ultrasonic scalpels reprocessed by Vanguard Medical Concepts Inc. are "substantially equivalent" to new and has cleared the company to resume sales of the product. Vanguard voluntarily removed the scalpels from the market last fall pending an FDA request for additional documentation of the company's methodology for cleaning, testing and sterilizing the costly devices.
Infection Control Today (http://www.infectioncontroltoday.com/hotnews/53h292153768056.html)
KEYWORDS FDAnews Device Daily Bulletin
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