CrossBay Endometrial Tissue Sampler (ETS)— 510(k) K192534

Name: FDA 510(k) clearance K192534
Creator: U.S. Food and Drug Administration
Published: 2020-03-25

Substantially Equivalent

Crossbay Medical

FDA 510(k) clearance K192534 for CrossBay Endometrial Tissue Sampler (ETS), Substantially Equivalent on 2020-03-25. 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: 2019-09-16
Decision date: 2020-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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