FDA Browser

Last synced on 14 November 2025 at 11:06 pm

subpart-e—surgical-devices/

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

Page Type: Cleared 510(K)
PDF: Full PDF / Letter
510(k) Number: K243713
510(k) Type: Traditional
Applicant: Agnes Medical Co., Ltd.
Country: South Korea
FDA Decision: Substantially Equivalent
Decision Date: 8/19/2025
Days to Decision: 260 days
Submission Type: Summary

FDA Browser

subpart-e—surgical-devices/

Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

Page Type: Cleared 510(K)
PDF: Full PDF / Letter
510(k) Number: K243713
510(k) Type: Traditional
Applicant: Agnes Medical Co., Ltd.
Country: South Korea
FDA Decision: Substantially Equivalent
Decision Date: 8/19/2025
Days to Decision: 260 days
Submission Type: Summary