FDA.reportPublic FDA data

Flexible Video-Choledo-Cysto-Ureteroscope

Primary DI
06973786291396
Brand
Flexible Video-Choledo-Cysto-Ureteroscope
Company
Shanghai SeeGen Photoelectric Technology Co., Ltd
Model
UV-US100-H(STD)
Published
2024-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBNCholedochoscope 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
06973786291396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973786291396069737862913966973786291396

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
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(STD)2024-09-14
06973786290627Flexible Video-Choledo-Cysto-UreteroscopeUV-US100-H(REV)2023-07-26
06973786290634Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(REV)2023-07-26
06973786290580Flexible Video-Choledo-Cysto-UreteroscopeUV-100-E2023-07-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04055207007792NARichard Wolf GmbHFBN2026-05-29
04055207007815NARichard Wolf GmbHFBN2026-05-29
04055207007839NARichard Wolf GmbHFBN2026-05-29
04055207008409NARichard Wolf GmbHFBN2026-05-29
04055207038505RIWORichard Wolf GmbHFBN2026-05-29
04055207038529RIWORichard Wolf GmbHFBN2026-05-29
04055207038536RIWORichard Wolf GmbHFBN2026-05-29
00850061601001Tangent Digital catheterTangent Endoscopy LLCFBN2026-04-08
06932503571210eyeMAX(TM) PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.FBN2025-04-25
26932503571214eyeMAX(TM) PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.FBN2025-04-25
06973786291563Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2025-03-20
16973786290518Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2025-03-20
06973786291570Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2025-03-19
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2025-02-28
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2024-09-14
04055207038512RIWORichard Wolf GmbHFBN2024-08-19
04055207008607NARichard Wolf GmbHFBN2024-08-19
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCFBN2024-07-22
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546290Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546306Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546313Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
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