Hello Anon,
As indicated by the previous post, you can have one (1) 510(k) number associated with multiple Medical Device Listings, because there may be different Trade Names or Proprietary names associated with the same product. The product would be exactly the same under the different Medical Device Listing with maybe differences in accessories listed or Trade Name/marketing names. You would not have two (2) 510(k) numbers under one listing, because during the entry in the FURLS system you are selecting one 510(k) number.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 30-Mar-2024 17:51
From: Anonymous Member
Subject: More than one 510k per listing
This message was posted by a user wishing to remain anonymous
Hello Anon
No, it's one listing per 510(k). You don't get to choose your listing number. You just enter the 510(k) number and FDA will generate a new listing number for it.
https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list
Or did you mean multiple products under the same 510(k)? In that case, yes. You just select the listing and add more proprietary names to it.
Original Message:
Sent: 26-Mar-2024 16:17
From: Anonymous Member
Subject: More than one 510k per listing
This message was posted by a user wishing to remain anonymous
Hello,
The initial and annual registration instructions (FDA) do not specify if one can add another 510(k) device to an existing listing (two under one listing). Does anyone know if this can be done, and if so, are there instructions on how to accomplish it? Thanks for any and all input.