The NovaSure®Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre
815012US - 815012US
Device Description
An electrically-powered device intended to produce radio-frequency (RF) energy at a predetermined power (based on uterus size) for coagulation/ablation of the endometrium with a handpiece/electrode (not included) to treat menorrhagia. The RF generator is also intended to facilitate carbon dioxide (CO2) delivery from a CO2 cartridge for assessment of uterine cavity integrity (intactness), and includes a suction pump intended to facilitate constant contact between the electrode and endometrium. It is intended to monitor tissue impedance [resistance of the tissue to alternating electrical current (AC)] to automatically interrupt ablation at a pre-set impedance threshold.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MNB
Device Name: Device, Thermal Ablation, Endometrial
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 25420045505398
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 15420045505391
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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