CrossGlide ETS Plus— 510(k) K201952

Substantially Equivalent

Crossbay Medical

FDA 510(k) clearance K201952 for CrossGlide ETS Plus, Substantially Equivalent on 2020-08-05. Applicant: Crossbay Medical. Device class: 2.

Clearance details

Applicant: Crossbay Medical
Product code: Code HHK
Device class: Class 2
Regulation: 21 CFR 884.1175
Advisory panel: Obstetrics/Gynecology
Date received: 2020-07-14
Decision date: 2020-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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