It is almost a given, they are rarely denied a patent in these circumstances.
In regards to 510K easier to post a link
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm
The costs etc to do with having a "generic" ReCell are many especially with a device like ReCell much more than a medicine which is a simple formula. Molds for the device which are expensive to design, make and the testing of the device working the same, it's not as bad as all th full clinical trials etc, but, it's just a lot more money, risk etc for something where the majority of the US market will be closed to them. I don't see it being worth it.
It is almost a given, they are rarely denied a patent in these...
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