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510(k) Data Aggregation
K Number
K241271Device Name
Aqua Medical RF Vapor Ablation System
Manufacturer
Aqua Medical, Inc.
Date Cleared
2024-12-12
(220 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Aqua Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
Device Description
The Aqua RF Vapor Ablation System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor Ablation System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using radiofrequency (RF) energy. Application of heat to the tissue results in coagulation and ablation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF VaporAblation System consists of the following components:
- Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter.
- Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7F -(2.3 mm) with an outer catheter sheath that is 10.5F and a length between 145 cm and 210 cm. There are 3 types of RF Vapor catheters available. Catheters are designed to be used through an endoscope working channel diameter of 3.7mm.
- Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
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K Number
K213627Device Name
RF Vapor System
Manufacturer
Aqua Medical, Inc.
Date Cleared
2021-12-17
(30 days)
Product Code
KNS, GEI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Aqua Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
Device Description
The Aqua RF Vapor System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using radiofrequency (RF) energy. Application of heat to the tissue results in coagulation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF Vapor System consists of the following components: Aqua RF Vapor Generator: A software-controlled RF generator is operated i through a graphical user interface (GUI) and incorporates a svringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter. Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7 F (2.3 mm) and a lengths between145 cm and 210 cm. There are 4 types of RF Vapor catheters available. Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
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K Number
K211282Device Name
Aqua Medical RF Vapor System
Manufacturer
Aqua Medical, Inc.
Date Cleared
2021-05-27
(30 days)
Product Code
KNS, GEI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Aqua Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
Device Description
The Aqua RF Vapor System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using RF (radiofrequency) energy. Application of heat to the tissue results in coagulation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF Vapor System consists of the following components:
- Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter.
- Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7 F (2.3 mm) and a length of 145 cm. There are 3 types of RF Vapor catheters available.
- Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
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K Number
K183595Device Name
Aqua Medical RF Vapor System
Manufacturer
Aqua Medical, Inc.
Date Cleared
2019-06-21
(182 days)
Product Code
KNS, GEI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Aqua Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
Device Description
The Aqua RF Vapor System uses a catheter to deliver heat to the tissue surface undergoing treatment. The heat, which is created by the application of RF energy to a bipolar electrode pair located inside the catheter tip, is delivered to the tissue through heated water vapor generated inside the catheter. Application of heat to the tissue results in coagulation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue.
The Aqua Medical RF Vapor System consists of the following components:
- Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter.
- Aqua RF Vapor Catheter: a disposable, sterile, single-use catheter with a diameter of 7 F (2.3 mm) and a length of 145 cm. It includes an integrated cable for attachment to the generator and a Luer-connector that facilitates connection to the saline delivery tubing.
- Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) that provide a means of delivering saline to the catheter during treatment.
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