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  Post Number #1  
Old 1st February 2018, 10:57 PM
Siddhartha230

 
 
Total Posts: 2
Question 510(k) statement or 510(k) summary ?

Hi All,

Can anyone tell me, why some medical devices have the detailed 510(k) summary in the 510(k) search database, but some only have the brief 510(k) statement?

Here are the examples:

1. K153283, VivoSight Dx Topical OCT System, only has the brief 510(k) statement in the database, but

2. K160878, OPTIS Metallic Stent Optimization E.4 SW, has the detailed 510(k) summary in the database,

even though these two devices have the same Regulation Number (892.1560).

Thanks.

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  Post Number #2  
Old 2nd February 2018, 03:37 AM
bio_subbu's Avatar
bio_subbu

 
 
Total Posts: 626
Re: 510(k) statement or 510(k) summary ?

Quote:
In Reply to Parent Post by Siddhartha230 View Post

Hi All,

Can anyone tell me, why some medical devices have the detailed 510(k) summary in the 510(k) search database, but some only have the brief 510(k) statement?

Here are the examples:

1. K153283, VivoSight Dx Topical OCT System, only has the brief 510(k) statement in the database, but

2. K160878, OPTIS Metallic Stent Optimization E.4 SW, has the detailed 510(k) summary in the database,

even though these two devices have the same Regulation Number (892.1560).

Thanks.
It's a manufacturer choice to choose either to submit a 510(k) summary or a statement. If manufacturer submitted a 510(k) statement, the detailed 510(k) won't be available in the database, but its 510(k) owners responsibility to provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request. you can contact the company directly, and you will get the redacted copies of 510(k) (with patient identifiers, trade secret and confidential information deleted).

See the link on Content of a 510(k), Content of a 510(k) and refer particularly Sec. 807.93 Content and format of a 510(k) statement, Or you can request 510k through the FDA FOIA (Freedom of Information Act).

Last edited by bio_subbu; 2nd February 2018 at 03:48 AM. Reason: added FDA links
Thanks to bio_subbu for your informative Post and/or Attachment!
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