4K UHD Laparoscope

Primary DI
06971381252125
Brand
4K UHD Laparoscope
Company
Scivita Medical Technology Co., Ltd.
Model
4K5530L
Device description
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, 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 visualization of biliary duct, colon, liver and uterus.4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
Published
2023-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
IZISystem, X-Ray, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221252000Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.2023-01-13GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971381252122PackageGS12In Commercial Distribution
06971381252125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697138125212216971381252122
06971381252125069713812521256971381252125

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization"", ""High-level Disinfectant""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization
Hydrogen Peroxide;Moist Heat or Steam Sterilization;High-level Disinfectant

Regulatory Flags#

DUNS number
544519831
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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