FDA.reportPublic FDA data

Endoso

Primary DI
06975202770348
Brand
Endoso
Company
Hunan Endoso Life Technology Co., Ltd
Model
4KA30
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
06975202770348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975202770348069752027703486975202770348

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269555Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269562Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269579Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269593Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
04995047072416CuratOREIZO CORPORATIONGCJ2026-09-25
00190776432348MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432386MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432416MillenniumAvalign Technologies, Inc.GCJ2026-09-24