FDA 510(k)

Aqueduct 100 Cervical Dilator

K-Number: K160664 · 2016-08-01

Decision Date2016-08-01

Product CodePON

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Aqueduct 100 Cervical Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Gtimd, LLC. It received FDA 510(k) clearance on 2016-08-01 under 510(k) 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. The listed applicant is Gtimd, LLC. The 510(k) number is K160664.

When did Aqueduct 100 Cervical Dilator receive FDA 510(k) clearance?

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

Who is the listed applicant for Aqueduct 100 Cervical Dilator?

The FDA 510(k) record lists Gtimd, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Gtimd, LLC 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.

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

Related Devices (Code: PON)

K202433Aqueduct 200 Cervical Dilation Balloon CatheterGtimd, LLC K202427Aqueduct 100 Plus Cervical Dilation Balloon CatheterGtimd, LLC K190813CrossBay Cervical Dilator Catheter SystemCrossbay Medical

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.