In Brief: Conceptus
This article was originally published in The Gray Sheet
Conceptus: Receives FDA letter stating falloposcopes used to evaluate proximal tubal occlusion in the fallopian tube will be reviewed via the 510(k) route. "Clinical data will be required to support a 510(k) application for falloposcopy devices for this indication," the company says, and "data in the 510(k) application should support substantial equivalence of the falloposcope to selective salpingography catheters and hysteroscopes." Conceptus, which submitted a 510(k) with clinical data in June for its Fallopian Tube Catheterization with Microendoscopy (FTCM) system ("The Gray Sheet" July 15, In Brief), petitioned FDA in October 1995 to downclassify falloposcopes to Class II...
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