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510(k) Data Aggregation
K Number
K232902Device Name
EVA15 insufflator
Manufacturer
Palliare Ltd.
Date Cleared
2024-05-02
(227 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Palliare Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
Device Description
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit, and (2) a disposable tube set.
The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25 mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.
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K Number
K230474Device Name
EVA5 Insufflator
Manufacturer
Palliare Ltd.
Date Cleared
2023-03-24
(30 days)
Product Code
FCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Palliare Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.
Device Description
The EVA5 insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. It is indicated to facilitate the introduction of various endoscopic instruments by filling the alimentary canal with gas to distend it. The EVA5 Insufflator is used in an operating room or endoscopic suite. It consists of the following major component (1) a micro-processor-controlled insufflation flow control system.
The EVA5 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate the alimentary canal via an endoscope. The EVA5 is powered by AC and uses a compressed 50 psi CO2 gas supply to supply the pneumatic circuitry for insufflation.
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K Number
K222901Device Name
EVA15 insufflator
Manufacturer
Palliare Ltd.
Date Cleared
2023-01-27
(126 days)
Product Code
HIF, FCX
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Palliare Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVA 15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
Device Description
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.
The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.
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K Number
K202922Device Name
END 200 Endoscopic Tubeset
Manufacturer
Palliare Ltd.
Date Cleared
2021-07-08
(282 days)
Product Code
FCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Palliare Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The END-200 Tubeset is intended to be used with the EVA15 insufflator, to supply CO2 to an endoscope during gastrointestinal endoscopic procedures.
Device Description
The END-200 Tubeset is a dual lumen tube with clips that attach to the outside of an endoscope. It connects to a CO2 gas source and is used to insufflate the cavity during an endoscopic procedure, and to provide a line to monitor pressure. It is single use, disposable and provided non-sterile similar to the predicate. The ENDO-200 Tubeset is offered in Small and Medium sizes.
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K Number
K202799Device Name
EVA15
Manufacturer
Palliare Ltd.
Date Cleared
2020-10-21
(28 days)
Product Code
HIF, FCX
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Palliare Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVA15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
Device Description
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.
There are 3 operating modes:
- (a) Continuous Flow (similar to a traditional endoscopic insufflator) delivers a fixed flow between 0 and 15 standard liters per minute (SLPM)
- (b) Intermittent Pressure Insufflation (similar to traditional laparoscopic insufflation) a pressure is targeted, but the flow delivered in targeting that pressure is limited to 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- (c) Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is limited to 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).
The tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation respectively.
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K Number
K193520Device Name
EVA 15 Insufflator
Manufacturer
Palliare Ltd.
Date Cleared
2020-07-23
(217 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Palliare Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, colon or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
Device Description
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflation is intended to use in hospital. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.
There are 3 operating modes:
- Flow Mode (1) delivers a fixed flow, settable between 0 and 15 standard liters per minute (SLPM)
- Pressure Modes (2) -
- Intermittent Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).
The tubeset is a sterile, single-use product. The tubeset is made of PVC and polyethylene. The A VA 15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation, respectively.
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