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 a medical device manufactured by Crossbay Medical. It received FDA 510(k) clearance on 2020-03-25 under approval 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. It is manufactured by Crossbay Medical. The 510(k) number is K192534.
When was CrossBay Endometrial Tissue Sampler (ETS) approved by the FDA?
CrossBay Endometrial Tissue Sampler (ETS) received FDA 510(k) clearance on 2020-03-25, under approval number K192534.
What company makes CrossBay Endometrial Tissue Sampler (ETS)?
CrossBay Endometrial Tissue Sampler (ETS) is manufactured by Crossbay Medical.
What is the FDA product code for CrossBay Endometrial Tissue Sampler (ETS)?
The FDA product code for CrossBay Endometrial Tissue Sampler (ETS) is HHK.
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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.