How long does a 510(k) submission take to get cleared?

[@Peaceseeker917]

I would like to sell Derma roller that have needle sizes over 0.3mm. Amazon won't let me sell it unless I have 510k clearance. Can I get cleared for this product?

[@MedicalDeviceAcademy]

This is very common. We see companies selling products from other countries that the FDA requires 510(k) clearance for. The problem is that the devices require the testing data before the FDA will clear it. The testing for biocompatibility can cost as much as our preparation of the 510(k). Cleaning validation can cost even more, and you also have to pay the FDA user fee.

[@Peaceseeker917]

How much roughly do you think it will cost?