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I thought I had read in the regulations that two 510(k)s for one device cannot be under review at the same time. That is, for any one device, if for some reason the two topics cannot be submitted in one 510(k), then a second 510(k) should not be submitted until the first 510(k) has cleared or been withdrawn. ...

While all good points, the date on the publicly available database of 510(k) clearance is based upon the final 510(k) Summary document that was updated due to the additional work required to end the review and not the date the submission was accepted by the FDA initially. As a result, the date on the ...

This question is a tad hard to answer without a bit more information, mainly it would help to know why you think you need this new, 3rd device for your argument and whether you do indeed plan to have 2 predicate devices. But, my first reaction is that if clinical data are necessary for your submission, ...

Yes-- until the clearance letter is issued, you can work with the lead reviewer on several items related to the submission. I had marketing want to change the name of a device while in the midst of a review and so I wanted the clearance letter to state the new name rather than the name under which it ...

A company has a cystoscope cleared for urological use via a 510(k) and then we took that exact same scope and sent it to the OBGYN section of CDRH and just received clearance for it to be used as a hysteroscope. Again, both are the exact same device but now with 2 different intended use statements. Marketing ...