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FDA 510(k)

CrossBay Endometrial Tissue Sampler (ETS)

K-Number: K192534 · 2020-03-25

ApplicantCrossbay Medical
Decision Date2020-03-25
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CrossBay Endometrial Tissue Sampler (ETS) is the device name listed in this FDA 510(k) record. The listed applicant is Crossbay Medical. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K192534. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CrossBay Endometrial Tissue Sampler (ETS)?

CrossBay Endometrial Tissue Sampler (ETS) is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Crossbay Medical. The 510(k) number is K192534.

When did CrossBay Endometrial Tissue Sampler (ETS) receive FDA 510(k) clearance?

CrossBay Endometrial Tissue Sampler (ETS) received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192534.

Who is the listed applicant for CrossBay Endometrial Tissue Sampler (ETS)?

The FDA 510(k) record lists Crossbay Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CrossBay Endometrial Tissue Sampler (ETS)?

The FDA product code for CrossBay Endometrial Tissue Sampler (ETS) is HHK.

Other records listing Crossbay Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201952CrossGlide ETS PlusK190813CrossBay Cervical Dilator Catheter SystemK162064CrossBay IVF Embryo Transfer Catheter Set

Related Devices (Code: HHK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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