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FDA 510(k)

CrossBay Cervical Dilator Catheter System

K-Number: K190813 · 2019-08-23

ApplicantCrossbay Medical
Decision Date2019-08-23
Product CodePON
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CrossBay Cervical Dilator Catheter System is a medical device manufactured by Crossbay Medical. It received FDA 510(k) clearance on 2019-08-23 under approval number K190813. The device is classified under product code PON. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CrossBay Cervical Dilator Catheter System?

CrossBay Cervical Dilator Catheter System is a medical device that received FDA 510(k) clearance on 2019-08-23. It is manufactured by Crossbay Medical. The 510(k) number is K190813.

When was CrossBay Cervical Dilator Catheter System approved by the FDA?

CrossBay Cervical Dilator Catheter System received FDA 510(k) clearance on 2019-08-23, under approval number K190813.

What company makes CrossBay Cervical Dilator Catheter System?

CrossBay Cervical Dilator Catheter System is manufactured by Crossbay Medical.

What is the FDA product code for CrossBay Cervical Dilator Catheter System?

The FDA product code for CrossBay Cervical Dilator Catheter System is PON.

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Other Devices by Crossbay Medical

K201952CrossGlide ETS Plus K192534CrossBay Endometrial Tissue Sampler (ETS)

Related Devices (Code: PON)

K160664Aqueduct 100 Cervical DilatorGtimd, LLC K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC

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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