NSV5US-001: Hologic NovaSure V5 Impedance Controlled Endometrial Ablation Kit

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Hologic NSV5US-001 NovaSure V5 Endometrial Ablation Device Kit

The Hologic NSV5US-001 is the NovaSure V5 Impedance Controlled Endometrial Ablation disposable device kit, designed for treating abnormal uterine bleeding in premenopausal women. Manufactured by Hologic, this kit provides the single-use components for the NovaSure V5 procedure, known for its quick (~90 second) treatment time. Key system technologies include impedance-controlled SmartDepth™ ablation, SureClear™ fluid removal, and V5 enhancements like the Endoform™ seal and AccuSheath™ markings for accurate placement. The system performs a pre-procedure cavity integrity assessment for safety.

Product Code NSV5US-001

• Type: Impedance Controlled Endometrial Ablation Device Kit
• System: NovaSure V5
• Technology: SmartDepth™, SureClear™, Endoform™ Seal, AccuSheath™ Markings
• Sheath Size: 6 mm OD
• Application: Endometrial Ablation for Abnormal Uterine Bleeding

Contents

• NovaSure V5 Disposable Device (Sterile, Single-Use)
• Suction Line Desiccant (Non-Sterile, Single-Use)

Features

• NovaSure V5 disposable device with integrated electrode array
• Impedance-controlled ablation with SmartDepth™ technology
• SureClear™ technology for integrated fluid/vapor removal
• Endoform™ cervical seal accommodates varied anatomy
• AccuSheath™ markings (6mm sheath) aid placement accuracy
• Pre-procedure Cavity Integrity Assessment (CIA) function
• Average treatment time ~90 seconds

Sterilization

• Device Packaged as Sterile: Yes
• Requires Sterilization Prior to Use: No
• Single-Use, Disposable: Yes 

Additional Details

• Brand: Hologic NovaSure®
• Category: Gynecological Surgical Devices
• Type: Endometrial Ablation Kit
• FDA Product Code: MNB
• FDA Product Code Name: Device, Thermal Ablation, Endometrial
• GMDN Term Code: 66632
• GMDN Term Name: Radio-frequency endometrial-ablation system handpiece/electrode
• GMDN Term Definition: A combined handpiece and bipolar electrode array intended to be introduced into the uterine cavity to deliver radio-frequency (RF) current for coagulation/ablation of the endometrium to treat menorrhagia. It is designed to be inserted without imaging whereby the electrode array is expanded in situ to achieve full endometrium contact. It includes tubing for delivery of carbon dioxide (CO2) to assess uterine cavity integrity (intactness), and for suction to clear and maintain endometrium contact within the cavity; ablation is automatically interrupted at a pre-set impedance threshold. This is a single-use device.

Hologic is a leading healthcare innovator specializing in advanced diagnostic and surgical technologies, prominently known for women’s health and imaging solutions. Their comprehensive product range includes the NovaSure® endometrial ablation system, MyoSure® tissue removal system, and innovative diagnostic platforms like the ThinPrep® Pap Test and Panther® system. With a commitment to early detection and minimally invasive treatment, Hologic consistently delivers clinically proven products that enhance patient outcomes and improve procedural efficiency.