Circon Files Lithotriptor 510(k) In Response To FDA Warning
This article was originally published in The Gray Sheet
Circon's submission of a 510(k) application for its electrohydraulic lithotriptor and sterile probe system earlier this month follows a Jan. 28 warning letter issued by the agency. The firm is seeking indications for the fragmentation of stones in the bladder, urethra, kidneys and biliary calculi.
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