FDA.reportPublic FDA data

510(k) K240798

Device
Cntrl+ Bladder Support Pessary
Applicant
Cntrl+, Inc.
510(k) number
K240798
Product code
HHW
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-17
Date received
2024-03-22
Regulation
884.3575
Classification name
Pessary, Vaginal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karen Brunet
Address
501 Campbell St. Unit 3b Cornwall CA K6H6X5 K6H6X5

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K190277ProVate Vaginal SupportContipi Medical , Ltd.2019-07-08
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K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation2018-10-31
K153422Panpac Disposable Pessary Fitting SetPanpac Medical Corporation2016-07-14
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K132313PESSARYEis Corporation2014-12-05
K132670PANPAC INFLATABLE DOCUT PESSARYPanpac Medical Corporation2014-06-04
K131198TIPI OTCContipi , Ltd.2013-08-27
K092981PANPAC VAGINAL PESSARYPanpac Medical Corporation2010-07-22