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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 the device name listed in this FDA 510(k) record. The listed applicant is Gtimd, LLC. It received FDA 510(k) clearance on 2020-11-06 under 510(k) 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. The listed applicant is Gtimd, LLC. The 510(k) number is K202427.

When did Aqueduct 100 Plus Cervical Dilation Balloon Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Aqueduct 100 Plus Cervical Dilation Balloon Catheter?

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 Plus Cervical Dilation Balloon Catheter?

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

Related Clinical Trials

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.

NCT06799052Cervical Preparation for Same-Day Dilation & EvacuationRECRUITINGNCT07690007Combined Misoprostol and Cervical Balloon vs Misoprostol Alone for Induction on the First Day in PrimiparasNOT_YET_RECRUITINGNCT06591247Membrane Stripping for Cervical RipeningRECRUITINGNCT06850974Foley Balloon for Cervical Preparation Before Dilation and EvacuationRECRUITINGNCT06964373Cervical Ripening Balloons for Same-Day Cervical PrepRECRUITINGNCT07006896Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and OxytocinACTIVE_NOT_RECRUITING

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 CatheterK160664Aqueduct 100 Cervical Dilator

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, LLCK190813CrossBay Cervical Dilator Catheter SystemCrossbay MedicalK160664Aqueduct 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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