Cleared Special

CrossGlide ETS Plus

K201952 · Crossbay Medical · Obstetrics & Gynecology
Aug 2020
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K201952 is an FDA 510(k) clearance for the CrossGlide ETS Plus, a Curette, Suction, Endometrial (and Accessories) (Class II — Special Controls, product code HHK), submitted by Crossbay Medical (San Diego, US). The FDA issued a Cleared decision on August 5, 2020, 22 days after receiving the submission on July 14, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1175.

Submission Details

510(k) Number K201952 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2020
Decision Date August 05, 2020
Days to Decision 22 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HHK — Curette, Suction, Endometrial (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1175

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