FDA.reportPublic FDA data

4K UHD Laparoscope

Primary DI
06971381250275
Brand
4K UHD Laparoscope
Company
Scivita Medical Technology Co., Ltd.
Model
4K1045R
Device description
The product is composed of eyepiece, lens body, optic fiber interface.The 4K UHD Laparoscope is intended to be used for 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.
Published
2023-05-17
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
HETLaparoscope, Gynecologic (And Accessories)
NMHLaparoscope And Accessories, Gynecologic, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
NMHLaparoscope And Accessories, Gynecologic, ReprocessedObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203255000
K221252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2032550004K UHD LaparoscopeScivita Medical Technology Co., Ltd.2021-02-24GCJ
K221252000Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.2023-01-13GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971381250272PackageGS12In Commercial Distribution
06971381250275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697138125027216971381250272
06971381250275069713812502756971381250275

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 Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971381254228Single-use Flexible UreteroscopeSUV-2C-B2026-07-16
06971381252736Single-use Extraction BasketsEBF-1529CG2024-12-06
06971381252743Single-use Extraction BasketsEBF-1511CG2024-12-06
06971381252750Single-use Extraction BasketsEBF-1511SG2024-12-06
06971381252767Single-use Extraction BasketsEBF-1506SG2024-12-06
06971381252774Single-use Extraction BasketsEBF-1506CG2024-12-06
06971381252781Single-use Extraction BasketsEBF-1507SG2024-12-06
06971381252798Single-use Extraction BasketsEBF-1507CG2024-12-06
06971381252804Single-use Extraction BasketsEBF-1508SG2024-12-06
06971381252811Single-use Extraction BasketsEBF-1508CG2024-12-06
06971381252828Single-use Extraction BasketsEBF-2029SG2024-12-06
06971381252835Single-use Extraction BasketsEBF-2029CG2024-12-06
06971381252903Single-use Extraction BasketsEBF-2006SG2024-12-06
06971381252910Single-use Extraction BasketsEBF-2006CG2024-12-06
06971381252927Single-use Extraction BasketsEBF-2007SG2024-12-06
06971381252934Single-use Extraction BasketsEBF-2007CG2024-12-06
06971381252941Single-use Extraction BasketsEBF-2008SG2024-12-06
06971381252958Single-use Extraction BasketsEBF-2008CG2024-12-06
06971381252729Single-use Extraction BasketsEBF-1529SG2024-12-06
06971381253146Single-use Biopsy ForcepsBFUW-1029P-YG2023-12-28

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