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FDA 510(k)

Aqueduct 100 Cervical Dilator

K-Number: K160664 · 2016-08-01

ApplicantGtimd, LLC
Decision Date2016-08-01
Product CodePON
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Aqueduct 100 Cervical Dilator is a medical device manufactured by Gtimd, LLC. It received FDA 510(k) clearance on 2016-08-01 under approval number K160664. 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 Cervical Dilator?

Aqueduct 100 Cervical Dilator is a medical device that received FDA 510(k) clearance on 2016-08-01. It is manufactured by Gtimd, LLC. The 510(k) number is K160664.

When was Aqueduct 100 Cervical Dilator approved by the FDA?

Aqueduct 100 Cervical Dilator received FDA 510(k) clearance on 2016-08-01, under approval number K160664.

What company makes Aqueduct 100 Cervical Dilator?

Aqueduct 100 Cervical Dilator is manufactured by Gtimd, LLC.

What is the FDA product code for Aqueduct 100 Cervical Dilator?

The FDA product code for Aqueduct 100 Cervical Dilator is PON.

Other Devices by Gtimd, LLC

K202427Aqueduct 100 Plus Cervical Dilation Balloon Catheter K202433Aqueduct 200 Cervical Dilation Balloon Catheter

Related Devices (Code: PON)

K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical 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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