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FDA 510(k)

Aqueduct 200 Cervical Dilation Balloon Catheter

K-Number: K202433 · 2021-10-15

ApplicantGtimd, LLC
Decision Date2021-10-15
Product CodePON
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Aqueduct 200 Cervical Dilation Balloon Catheter is a medical device manufactured by Gtimd, LLC. It received FDA 510(k) clearance on 2021-10-15 under approval number K202433. 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 Aqueduct 200 Cervical Dilation Balloon Catheter?

Aqueduct 200 Cervical Dilation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2021-10-15. It is manufactured by Gtimd, LLC. The 510(k) number is K202433.

When was Aqueduct 200 Cervical Dilation Balloon Catheter approved by the FDA?

Aqueduct 200 Cervical Dilation Balloon Catheter received FDA 510(k) clearance on 2021-10-15, under approval number K202433.

What company makes Aqueduct 200 Cervical Dilation Balloon Catheter?

Aqueduct 200 Cervical Dilation Balloon Catheter is manufactured by Gtimd, LLC.

What is the FDA product code for Aqueduct 200 Cervical Dilation Balloon Catheter?

The FDA product code for Aqueduct 200 Cervical Dilation Balloon Catheter is PON.

Related Clinical Trials

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Other Devices by Gtimd, LLC

K160664Aqueduct 100 Cervical Dilator K202427Aqueduct 100 Plus Cervical Dilation Balloon Catheter

Related Devices (Code: PON)

K160664Aqueduct 100 Cervical DilatorGtimd, LLC K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical K202427Aqueduct 100 Plus 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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