CrossGlide ETS Plus
K-Number: K201952 · 2020-08-05
ApplicantCrossbay Medical
Decision Date2020-08-05
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
CrossGlide ETS Plus is a medical device manufactured by Crossbay Medical. It received FDA 510(k) clearance on 2020-08-05 under approval 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. It is manufactured by Crossbay Medical. The 510(k) number is K201952.
When was CrossGlide ETS Plus approved by the FDA?
CrossGlide ETS Plus received FDA 510(k) clearance on 2020-08-05, under approval number K201952.
What company makes CrossGlide ETS Plus?
CrossGlide ETS Plus is manufactured by Crossbay Medical.
What is the FDA product code for CrossGlide ETS Plus?
The FDA product code for CrossGlide ETS Plus is HHK.
Other Devices by Crossbay Medical
Related Devices (Code: HHK)
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.