Home / 510(k) Clearances / K230730

510(k) K230730

Apyx by Escala Medical — Product Code PBQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 25, 2023
Date Received: March 16, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Device Class: Class II
Regulation Number: 884.4530
Review Panel: OB
Submission Type

Attaching suture or stapling ligaments of the pelvic floor.