Endoso

Primary DI
06975202770355
Brand
Endoso
Company
Hunan Endoso Life Technology Co., Ltd
Model
4KA30R
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231725000Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)Hunan Endoso Life Technology Co., Ltd.2023-10-16GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975202770355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975202770355069752027703556975202770355

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.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide

Regulatory Flags#

DUNS number
722930494
Device count
1
DM exempt
true
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
06975202770287EndosoP1-A2025-11-28
06975202770294EndosoP1-B2025-11-28
06975202770300EndosoP1-C2025-11-28
06975202770317EndosoP1-D2025-11-28
06975202770478EndosoP1-E2025-11-28
06975202770485EndosoP2-A2025-11-28
06975202770492EndosoP2-B2025-11-28
06975202770508EndosoP2-C2025-11-28
06975202770515EndosoP2-D2025-11-28
06975202770522EndosoP2-E2025-11-28
06975202772878EndosoPUR12-S2025-11-28
06975202772908EndosoPUR12-42025-11-28
06975202772915EndosoPUR12-52025-11-28
06975202772922EndosoPUR12-62025-11-28
06975202772939EndosoPUR12-S12025-11-28
06975202772946EndosoPUR12-S22025-11-28
06975202773059EndosoPUR12-12025-11-28
06975202773073EndosoPUR12-32025-11-28
06975202773066EndosoPUR12-22025-11-26
06975202770102EndosoBC12-12024-07-12

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Primary DI, Brand, Company table
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08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
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08719324463126symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
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