U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. Search the Releasable 510(k) Database
  1. Device Approvals, Denials and Clearances

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

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