Last synced on 14 November 2025 at 11:06 pm

AGNES Ultra

Page Type
Cleared 510(K)
510(k) Number
K250217
510(k) Type
Traditional
Applicant
Agnes Medical Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
9/3/2025
Days to Decision
222 days
Submission Type
Summary

AGNES Ultra

Page Type
Cleared 510(K)
510(k) Number
K250217
510(k) Type
Traditional
Applicant
Agnes Medical Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
9/3/2025
Days to Decision
222 days
Submission Type
Summary