Cleared Traditional

Apyx

K230730 · Escala Medical · Obstetrics & Gynecology
Jul 2023
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K230730 is an FDA 510(k) clearance for the Apyx, a Fixation, Non-absorbable Or Absorbable, For Pelvic Use (Class II — Special Controls, product code PBQ), submitted by Escala Medical (Misgav, IL). The FDA issued a Cleared decision on July 25, 2023, 131 days after receiving the submission on March 16, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K230730 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2023
Decision Date July 25, 2023
Days to Decision 131 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code PBQ — Fixation, Non-absorbable Or Absorbable, For Pelvic Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530
Definition Attaching Suture Or Stapling Ligaments Of The Pelvic Floor.