Old thread, but new question. I wonder what do you mean by "variant"? can a variant of the legally marketed device use a different name? for example, the legally markted device is call YY010, and we have modify the colour of the device, (the modification will need no new 510(k), and "documentation" is enough) and call the colour-changed device YY020, then if the YY020 can be put on the market without a 510(k) submission? I mean, there is YY010 listed on the 510(k) clearance letter and in FDA's database, but YY020 is not there!
Thanks a lot!