Gynescope System— 510(k) K190187

Substantially Equivalent

Illumigyn , Ltd.

FDA 510(k) clearance K190187 for Gynescope System, Substantially Equivalent on 2019-05-08. Applicant: Illumigyn , Ltd.. Device class: 2.

Clearance details

Applicant: Illumigyn , Ltd.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2019-02-01
Decision date: 2019-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neve Ilan, 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.