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510(k) Data Aggregation
K Number
K180237Device Name
Rezum System
Manufacturer
NxThera, Inc.
Date Cleared
2018-02-27
(29 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
NxThera, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm3 and ≤ 80cm3. The Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
Device Description
The Rezum System consists of a reusable Generator and a sterile Delivery Device Kit consisting of one Delivery Device with cable and tubing, one syringe, one spike adaptor, and one 50mL sterile water vial. The Delivery Device is EtO sterilized.
The Rezūm System converts water into vapor outside of the body with the vapor delivered to the prostate tissue via a needle within the sterile Delivery Device. The vapor ablates the targeted tissue within the prostate via thermal ablation as energy is transferred from the vapor to the prostate tissue. The amount of vapor delivered is controlled by a Radiofrequency (RF) Generator which also control the amount of saline flush used to cool the urethra during the treatment.
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K Number
K160417Device Name
Rezum System
Manufacturer
NxThera, Inc.
Date Cleared
2016-03-17
(30 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
NxThera, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm³ and ≤ 80cm². The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
Device Description
The reusable Rezūm Generator is provided with the following reusable components:
- Generator
- One Power Cord
The Rezūm Delivery Device Kit contains the following disposable components:
- One sterile Delivery Device with cable and tubing
- One sterile Syringe
- One sterile Spike Adaptor
- One 50 ml Sterile Water Vial
Additional spike adaptor and syringe accessory is provided as an Accessory Pack.
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K Number
K150786Device Name
Rezum System
Manufacturer
NxThera, Inc.
Date Cleared
2015-08-27
(155 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
NxThera, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm³ and ≤ 80cm³. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
Device Description
The reusable Rezūm Generator is provided with the following reusable components:
- Generator
- One Power Cord
The Rezūm Delivery Device Kit contains the following disposable components:
- One sterile Delivery Device with cable and tubing
- One sterile Syringe
- One sterile Spike Adaptor
- One 50 ml Sterile Water Vial
Additional spike adaptor and syringe accessory is provided as an Accessory Pack.
Ask a Question
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