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How to deal with changed shared components in 510k

Asia78

Involved In Discussions
#1
Dear experts,
I have a questions related to a component which is used in multiple devices (different product codes). This component was cleared in a 510k (let's call it 111) with specific product code.
Now we need to make an update to that component but we would like to do it in another 510k: this existing 510k (222) was previously indicating that the device was using the component listed in k111.
Can we submit a new 510k (333) for changes to the k222, changing also the component that was cleared in k111?
There will be no changes in the use of the k111.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Dear experts,
I have a questions related to a component which is used in multiple devices (different product codes). This component was cleared in a 510k (let's call it 111) with specific product code.
Now we need to make an update to that component but we would like to do it in another 510k: this existing 510k (222) was previously indicating that the device was using the component listed in k111.
Can we submit a new 510k (333) for changes to the k222, changing also the component that was cleared in k111?
There will be no changes in the use of the k111.
Not sure what you mean.
If you could share the actual k numbers I could have a look. If you're concerned about exposure you can send me a PM.
 
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