510(k) K160664

Device: Aqueduct 100 Cervical Dilator
Applicant: GTIMD LLC
510(k) number: K160664
Product code: PON
Decision: Substantially Equivalent (SESE)
Decision date: 2016-08-01
Date received: 2016-03-09
Regulation: 884.4260
Classification name: Catheter, Balloon, Dilation Of Cervical Canal
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Abbreviated
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: RICHARD DEMELLO
Address: 6 Columbia Dr. Amherst NH US 03031 03031

Source Documents#

Other 510(k) Records For Product Code PON #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K202433	Aqueduct 200 Cervical Dilation Balloon Catheter	Gtimd, LLC	2021-10-15
K202427	Aqueduct 100 Plus Cervical Dilation Balloon Catheter	Gtimd, LLC	2020-11-06
K190813	CrossBay Cervical Dilator Catheter System	Crossbay Medical	2019-08-23

Legacy Summary#

summary

FDA Review#

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