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U.S. Department of Health and Human Services

Medical Devices

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Search the Releasable 510(k) Database

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:

Device Classification Name:
Regulation Number:
510(k) Number:
Device Name:
Applicant:
Contact:
Product Code:
Date Received:
Decision Date:
Decision:
Classification Advisory Committee:
Review Advisory Committee:
Summary or Statement

SUMMARY indicates that a summary of safety and effectiveness information is available from FDA

STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant

Types:

Traditional

Special

Abbreviated

Rescission

Evaluation of Automatic Class III Designation

Reviewed by Third Party (Y/N)
Expedited Review (Y/N)