FDA.reportPublic FDA data

Flexible Video-Choledo-Cysto-Ureteroscope

Primary DI
06973786290627
Brand
Flexible Video-Choledo-Cysto-Ureteroscope
Company
Shanghai SeeGen Photoelectric Technology Co., Ltd
Model
UV-US100-H(REV)
Published
2023-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211686000Flexible Video-Choledo-Cysto-Ureteroscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.2022-02-22FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973786290627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973786290627069737862906276973786290627

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video ureteroscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
416472832
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973786290368Disposable Endoscope Valves KitSG-DVK-FJ-7002024-10-25
06973786291563Flexible Video-CholedochoscopeCHV-110J-U2025-03-20
16973786290518Flexible Video-CholedochoscopeCHV-110J-U2025-03-20
06973786291570Flexible Video-CholedochoscopeCHV-US120J-U2025-03-19
06973786290559Flexible Video-Choledo-Cysto-UreteroscopeCHV-100-E2023-07-26
06973786290566Flexible Video-Choledo-Cysto-UreteroscopeCHV-100T-E2023-07-26
06973786290573Flexible Video-Choledo-Cysto-UreteroscopeCHV-US100-H2023-07-26
06973786290641Flexible Video-CholedochoscopeCHV-US100J-U2023-07-26
06973786290658Flexible Video-CholedochoscopeCHV-US110J-U2023-07-26
06973786290139lmaging Processor System (lncluding Light Source)PL-21002023-07-26
06973786290078lmaging Processor System (lncluding Light Source)PL-10002023-07-26
06973786290337Disposable Endoscope Valves KitSG-DVK-OL-2002024-10-25
06973786290344Disposable Endoscope Valves KitSG-DVK-OL-200E2024-10-25
06973786290375Disposable Endoscope Valves KitSG-DVK-FJ-700E2024-10-25
06973786290399Disposable Endoscope Valves KitSG-DVK-PT-I10902024-10-25
06973786290405Disposable Endoscope Valves KitSG-DVK-PT-I1090E2024-10-25
06973786291396Flexible Video-Choledo-Cysto-UreteroscopeUV-US100-H(STD)2024-09-14
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(STD)2024-09-14
06973786290634Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(REV)2023-07-26
06973786290580Flexible Video-Choledo-Cysto-UreteroscopeUV-100-E2023-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.FGB2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.FGB2026-05-05
10810068811107MONARCH™ Urology Irrigation CartridgeAuris Health, Inc.FGB2026-05-04
10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
06972520301216Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
00810116023370Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023417Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023523Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023585Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
06971176282924Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13