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K Number
K000340
Device Name
HYSTALOG HSG CATHETER
Manufacturer
ROCKET MEDICAL PLC
Date Cleared
2000-04-19

(76 days)

Product Code
HES
Regulation Number
884.1300
Type
Traditional
Panel
Obstetrics/Gynecology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 884.1300 Uterotubal carbon dioxide insufflator and accessories.

(a)
Identification. A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.(b)
Classification. Class II (performance standards).