FDA 510(k)

CrossGlide ETS Plus

K-Number: K201952 · 2020-08-05

Decision Date2020-08-05

Product CodeHHK

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

CrossGlide ETS Plus is the device name listed in this FDA 510(k) record. The listed applicant is Crossbay Medical. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K201952. 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 CrossGlide ETS Plus?

CrossGlide ETS Plus is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Crossbay Medical. The 510(k) number is K201952.

When did CrossGlide ETS Plus receive FDA 510(k) clearance?

CrossGlide ETS Plus received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201952.

Who is the listed applicant for CrossGlide ETS Plus?

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 CrossGlide ETS Plus?

The FDA product code for CrossGlide ETS Plus 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.

K192534CrossBay Endometrial Tissue Sampler (ETS)K190813CrossBay Cervical Dilator Catheter System K162064CrossBay IVF Embryo Transfer Catheter Set

Related Devices (Code: HHK)

K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation , Ltd.K192534CrossBay Endometrial Tissue Sampler (ETS)Crossbay Medical

Official Source

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