Mendit— 510(k) K260380

Substantially Equivalent

Escala Medical, Ltd.

FDA 510(k) clearance K260380 for Mendit, Substantially Equivalent on 2026-03-04. Applicant: Escala Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Escala Medical, Ltd.
Product code: Code PBQ
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2026-02-05
Decision date: 2026-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Misgav, IL

Download summary PDF View on FDA.gov ↗

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