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FDA 510(k)

Aqueduct 100 Plus Cervical Dilation Balloon Catheter

K-Number: K202427 · 2020-11-06

ApplicantGtimd, LLC
Decision Date2020-11-06
Product CodePON
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Aqueduct 100 Plus Cervical Dilation Balloon Catheter is a medical device manufactured by Gtimd, LLC. It received FDA 510(k) clearance on 2020-11-06 under approval number K202427. 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 100 Plus Cervical Dilation Balloon Catheter?

Aqueduct 100 Plus Cervical Dilation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-11-06. It is manufactured by Gtimd, LLC. The 510(k) number is K202427.

When was Aqueduct 100 Plus Cervical Dilation Balloon Catheter approved by the FDA?

Aqueduct 100 Plus Cervical Dilation Balloon Catheter received FDA 510(k) clearance on 2020-11-06, under approval number K202427.

What company makes Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

Aqueduct 100 Plus Cervical Dilation Balloon Catheter is manufactured by Gtimd, LLC.

What is the FDA product code for Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

The FDA product code for Aqueduct 100 Plus Cervical Dilation Balloon Catheter is PON.

Related Clinical Trials

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Other Devices by Gtimd, LLC

K160664Aqueduct 100 Cervical Dilator K202433Aqueduct 200 Cervical Dilation Balloon Catheter

Related Devices (Code: PON)

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