Apyx— 510(k) K230730

Substantially Equivalent

Escala Medical

FDA 510(k) clearance K230730 for Apyx, Substantially Equivalent on 2023-07-25. Applicant: Escala Medical. Device class: 2.

Clearance details

Applicant: Escala Medical
Product code: Code PBQ
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2023-03-16
Decision date: 2023-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Misgav, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBQ

K260380 — Mendit2026-03-04
K220420 — Saffron Fixation System2022-06-10
K213783 — Apyx2022-04-05
K160569 — NeuGuide2016-07-06
K130059 — ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP2013-07-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.