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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 the device name listed in this FDA 510(k) record. The listed applicant is Crossbay Medical. It received FDA 510(k) clearance on 2019-08-23 under 510(k) 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. The listed applicant is Crossbay Medical. The 510(k) number is K190813.

When did CrossBay Cervical Dilator Catheter System receive FDA 510(k) clearance?

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

Who is the listed applicant for CrossBay Cervical Dilator Catheter System?

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 Cervical Dilator Catheter System?

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

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 PlusK192534CrossBay Endometrial Tissue Sampler (ETS)K162064CrossBay IVF Embryo Transfer Catheter Set

Related Devices (Code: PON)

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.

K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLCK202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLCK160664Aqueduct 100 Cervical DilatorGtimd, 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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