Cleared Traditional

CrossBay Endometrial Tissue Sampler (ETS) (K192534) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192534 · Crossbay Medical · Obstetrics & Gynecology device
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Mar 2020
Decision
191d
Days
Class 2
Risk

K192534 is an FDA 510(k) clearance for the CrossBay Endometrial Tissue Sampler (ETS). 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 March 25, 2020 after a review of 191 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Crossbay Medical devices

Submission Details

510(k) Number K192534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2019
Decision Date March 25, 2020
Days to Decision 191 days
Submission Type Traditional
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
31d slower than avg
Panel avg: 160d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K192534.
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
CrossGlide ETS Plus
K201952 · Crossbay Medical · Aug 2020
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K771149 · C.R. Bard, Inc. · Jul 1977