Hardly have it,lol. First, do not compare high/ signifigant risk items with low risk/non-signifigant. All implantable items are high risk classified, due to being argued "life sustaining", with implanted and then removed items sometimes being qualified as class 2 510k admissable.
The vast majority of Bi-polar electrosurgical gensets are class 2, unlike old monopolar.
1-3 years is the accepted norm for class 3, that have been sent to, relegated to or submitted as a class 3, needing a Premarket approval proccess with the FDA. Not a Premarket notification/510k.
Depending on which source one uses, dated from what couple of years quoted from, class 2 time frame quotes are 4 mo.s to a year.
Don has said we're 510k, not PMA.
E.U. is not far removed in this approximation of risk factors and or versus need of supporting clinicals.
By the way, there are a couple of steps along the way in any application, anywhere, for any medical application as far as clinicals. Wayyyyyy before one gets to comparing 800 patient
studies, lmao guys. Your getting far afield here.
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