Search Results
Found 11 results
510(k) Data Aggregation
K Number
K241138Device Name
ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator
Manufacturer
LivsMed Inc.
Date Cleared
2024-11-15
(205 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArtiSeal Vessel Sealing System-ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on veins) up to and including 7 mm. It is indicated for use in general surgery.
The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.
Device Description
ArtiSeal Vessel Sealing System - ArtiSeal Instruments
The ArtiSeal Vessel Sealing System - ArtiSeal invasive invasive instruments which are used with electrosurgical generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired.
When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies a high frequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation.
During a procedure with this product, the jaw opens, and jaw closes if the grip lever pulled. In addition, the jaw is also bent up, down, left, and right within a range of ±80° or more by moving the grip up, down, left, and tight, and the jaw can also turn 360° when rotating the grip.
ArtiSeal Vessel Sealing System - ArtiSeal Generator
The ArtiSeal Vessel Sealing System - ArtiSeal Generator supplies RF energy to the ArtiSeal Instruments. This energy supply device uses a touchscreen interface and features a unique instrument connecting the ArtiSeal Instrument. By connecting the connector on the ArtiSeal Instrument connection socket, the energy supply device can provide energy to the electrode.
Ask a Question
K Number
K240657Device Name
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-
Manufacturer
LivsMed Inc.
Date Cleared
2024-06-06
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
Device Description
It uses the principle of applying high-frequency currents from the electrode to the human body to generate heat by bioimpedance when radio frequency (RF) energy from the electrosurgical unit applies an electric current to the electrode part, and using the generated heat to incise cellular tissues and cause coagulation. It is composed of a end-tip, Φ5, Φ8 diameter shaft, grip part, and electrosurgical unit connection electrode plug.
Ask a Question
K Number
K230498Device Name
ArtiSential Laparoscopic Instruments-Electrodes
Manufacturer
LivsMed Inc.
Date Cleared
2023-06-05
(101 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
Ask a Question
K Number
K230539Device Name
ArtiSential Laparoscopic Instruments-Electrodes
Manufacturer
LivsMed Inc.
Date Cleared
2023-04-27
(59 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
Ask a Question
K Number
K230499Device Name
ArtiSential Laparoscopic Instruments-Electrodes
Manufacturer
LivsMed Inc.
Date Cleared
2023-04-26
(61 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
Device Description
The ArtiSential Laparoscopic Instruments – Electrodes, Bipolar series(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series) are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
Ask a Question
K Number
K220384Device Name
ArtiSential Laparoscopic Instruments-Electrodes
Manufacturer
LivsMed Inc.
Date Cleared
2022-02-24
(14 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
Device Description
The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series and ABD02 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
Ask a Question
K Number
K212500Device Name
ArtiSential Trocar
Manufacturer
LivsMed Inc.
Date Cleared
2021-12-03
(116 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
Device Description
ArtiSential Trocar is for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. This device is a sterile, single-use instruments consisting of a main body, cannula, obturator. An optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. And a funnel serves as an instrument insertion guide and aids in the insertion of a passive multijoint surgical instrument into the cannula.
Ask a Question
K Number
K203580Device Name
ArtiSential Laparoscopic Instruments-Electrodes
Manufacturer
LivsMed Inc.
Date Cleared
2021-04-30
(144 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
Ask a Question
K Number
K200875Device Name
ArtiSential Laparoscopic Instruments - Electrodes
Manufacturer
LivsMed Inc.
Date Cleared
2020-06-17
(77 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
Device Description
The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series, and ABD02 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
Ask a Question
K Number
K200501Device Name
ArtiSential Laparoscopic Instrument-Electrodes
Manufacturer
LivsMed Inc.
Date Cleared
2020-05-11
(73 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LivsMed Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
Ask a Question
Page 1 of 2