A 510(k) is a formal attempt to convince the FDA that the device you want to market (you have to file 90 days before you start marketing) is as safe and effective something equivalent that’s already out there.
Halozyme Therapeutics Files 510(k) Application for Cumulase for In Vitro Fertilization Cumulase is a synthetic version of the cow and sheep enzymes taken from slaughtered animals that are used as an essential part of the the process of intracytoplasmic sperm injection (ICSI) for in vitro fertilization.
IVF grows more and more common around the world. Right now they’re saying this product has a a market 500,000 potential purchases per year worldwide. As treatment gets more effective and less difficult–and less expensive–the marketing will only grow.