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K Number
K240798
Device Name
Cntrl+ Bladder Support Pessary
Manufacturer
Cntrl+ Inc.
Date Cleared
2024-12-17

(270 days)

Product Code
HHW
Regulation Number
884.3575
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).