Cleared Special

K201952 - CrossGlide ETS Plus

K201952 is an FDA 510(k) clearance for CrossGlide ETS Plus, manufactured by Crossbay Medical. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Special 510(k) pathway after a 22-day FDA review.

K201952 · Crossbay Medical · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
22d
Days
Class 2
Risk

K201952 is an FDA 510(k) clearance for the CrossGlide ETS Plus. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Crossbay Medical (San Diego, US). The FDA issued a Cleared decision on August 5, 2020 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K201952

510(k) Number K201952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d faster than avg
Panel avg: 161d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

HHK Device Classification - Class 2, Special Controls

Product Code HHK Curette, Suction, Endometrial (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Domecus Consulting Services, LLC
Cindy Domecus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HHK Curette, Suction, Endometrial (and Accessories)

All 41
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K201952.
Uterine Aspiration Set
K251882 · Gcmedica Enterprise Ltd.(Wuxi) · Oct 2025
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
K240434 · Li Medical Corporation , Ltd. · Sep 2024
CrossBay Endometrial Tissue Sampler (ETS)
K192534 · Crossbay Medical · Mar 2020
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
K102847 · Jiangsu Suyun Medical Materials Co., Ltd. · Apr 2011
THE PANPAC SUCTION CURETTE
K092982 · Panpac Medical Corporation · Jul 2010
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
K051294 · Femspec LLC · Dec 2005
K201952 · CrossGlide ETS Plus
Download PDF FDA Summary Crossbay Medical