Last synced on 25 January 2026 at 3:41 am

AGNES

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203013
510(k) Type
Traditional
Applicant
Agnes Medical Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
7/14/2022
Days to Decision
651 days
Submission Type
Summary

AGNES

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203013
510(k) Type
Traditional
Applicant
Agnes Medical Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
7/14/2022
Days to Decision
651 days
Submission Type
Summary