Search Results
Found 9 results
510(k) Data Aggregation
K Number
K243708Device Name
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2025-03-27
(115 days)
Product Code
FGB, FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra. bladder, ureter and renal pelvis.
This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis.
This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.
Device Description
The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis.
The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two different treatment section (with or without suction section).
The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.
The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years.
The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.
Ask a Question
K Number
K240289Device Name
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2024-10-23
(265 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.
Device Description
Full HD Endoscopic Image Processor is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.
This product is composed of Full HD Endoscopic Image Processor host, foot switch, power cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional.
There are four models (HDVS-S200B, HDVS-S200B, HDVS-S200D) for Full HD Endoscopic Image Processor, and the difference between the four models is only the difference in structure configuration.
Ask a Question
K Number
K240192Device Name
Single-use Extraction Baskets
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2024-10-15
(265 days)
Product Code
LQR, LOR
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.
Device Description
The Single-use Extraction Baskets is a single-use, sterile, disposable device. It is intended for the endoscopic removal of stones and stone fragments in the biliary system. The device consists of basket, sheath, and handle components. The basket component is constructed of stainless steel/nitinol wires. And the basket is connected to the handle of the operating portion through the insertion portion. Activating the handle allows the basket to open or close. This device is not compatible with any mechanical lithotripter.
Ask a Question
K Number
K231521Device Name
Broncho Videoscope System
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2023-11-14
(172 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
Device Description
The subject device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.
Ask a Question
K Number
K222812Device Name
Insufflator
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2023-05-16
(239 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
Device Description
The subject device consists of an insufflator, a high pressure tube and a pneumoperitoneum tube. The insufflator is a microprocessor-controlled CO2 insufflator that consists of the following major components and features: housing, power supply, pressure reducers, venting system, fluid sensor, gas heater, various setting keys and display elements. The insufflator is not intended to enter the field and cannot be sterilized. The pneumoperitoneum tube shall be cleaned, disinfected, and sterilized prior to subsequent use.
Ask a Question
K Number
K221252Device Name
Scivita 4KINSIGHT ICG Imaging System
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2023-01-13
(256 days)
Product Code
GCJ, IZI
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.
Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Device Description
The subject device, Scivita 4KINSIGHT ICG Imaging System is consisting of a 4KINSIGHT UHD Fluorescence Imaging System including a 4K Fluorescence Camera Control Unit and a 4K Fluorescence camera head, a Near-Infrared LED Light Source and a 4K UHD Laparoscope.
The subject device can be offered in multiple configuration based on different combination of component models and subcomponent models. Details refer to Table 1 System Configuration.
The component, 4KINSIGHT UHD Fluorescence Imaging System, is designed to be used with endoscopes, light source, monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation. It is comprised of a 4K Fluorescence Camera Control Unit (model: 4KIR321, 4KIR311) and a 4K Fluorescence camera head (model 4KIR320C). The only difference between 4KIR321 and 4KIR3114K is: two HDMI output signal of 4KIR321 both are 4096×2160p; two HDMI output signal of 4KIR311 are respectively 4096×2160p and 1920×1080p.
The component, 4K UHD Laparoscope, is a rigid endoscope intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities. The subject device is also indicated for visualization of transanal and transvaginal applications.
The 4K UHD Laparoscope has 18 models which are available in two insertion widths (5.5 mm and 10 mm), four working lengths (290mm, 424mm, 450mm) and three different directions of view (0 ; 30 ° 45 9. The 4K UHD Laparoscope is a reusable device that is cleaned and sterilized before first use and each use.
Ask a Question
K Number
K210379Device Name
Broncho Videoscope System
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2021-07-28
(169 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.
This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.
This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor (HDVS-S100A and HDVS-S100D) to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
Device Description
The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and an Endoscopic Image Processor including the foot switch. The proposed device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi and lungs.
The Single-use Broncho Videoscope is a single use device. The Single-use Broncho Videoscope has six models which are available in three kinds of outer diameter of insertion (Φ2.8mm, Φ4.2mm and Φ5.6mm), one working length (600mm) and two different material of the insertion (Nylon and PEEK). The single-use Broncho Videoscope is a single-channel endoscope. Only one working channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.
The Single-use Broncho Videoscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.
Ask a Question
K Number
K203255Device Name
4K UHD Laparoscope
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2021-02-24
(112 days)
Product Code
GCJ, HET, NMH
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 4K UHD Laparoscope is intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.
Device Description
The 4K UHD Laparoscope is a rigid endoscope, which consists of lighting system and optical imaging system. The 4K UHD Laparoscope has 12 models which are available in two insertion portion widths (5.5 mm and 10 mm), four working lengths (290mm, 300mm, 320mm) and three different directions of view (0°, 30°, 45°). The 12 models are all connected with adaptor 2 for different brand source light. The 4K UHD Laparoscope can be connected to Scivita 4K UHD Camera System, Scivita LED Light Source or Wolf light source and SONY Monitor. The 4K UHD Laparoscope is a reusable device that is cleaned and steam sterilized before first use and each subsequent use.
Ask a Question
K Number
K200216Device Name
4K UHD Camera System
Manufacturer
Scivita Medical Technology Co., Ltd.
Date Cleared
2020-08-21
(206 days)
Product Code
HET, EOB, FET, FGB, GCJ, HRX, NWB
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
Scivita Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
4K UHD Camera System is used to provide imaging of the operative area in endoscopic surgery.
4K Camera Control Unit
The 4K camera control unit has been designed to be used with endoscopes, 4K camera head, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K camera head is compatible with the 4K camera control unit only.
4K Camera Head
The 4K camera head has been designed to be used with endoscopes, 4K camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Device Description
The proposed system, 4K UHD Camera System, comprises the 4K camera head, objective lens and power cable and video cables. The proposed system is reusable device, and provided non-sterile. The proposed camera head and should be cleaned and disinfected after each use.
The video cables include an SDI video cable and an HDMI video cable. The 4K camera control unit has two models (ES-CS4K100 and ES-CS4K200) with the only difference on signal output terminals, the detail difference refers to Table 3 of this document; the 4K camera head only has one model (ES-CS4K100C). Therefore, the 4K UHD Camera System is available in two models in combination of the 4K camera control unit and 4K camera head.
Ask a Question
Page 1 of 1