FDA.reportPublic FDA data

Flexible Video-Choledochoscope

Primary DI
06973786290641
Brand
Flexible Video-Choledochoscope
Company
Shanghai SeeGen Photoelectric Technology Co., Ltd
Model
CHV-US100J-U
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
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
K222261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222261000Flexible Video-Choledochoscope SystemShanghai SeeGen Photoelectric Technology Co., Ltd.2023-04-20FBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973786290235PackageGS18In Commercial Distribution
06973786290641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697378629023516973786290235
06973786290641069737862906416973786290641

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video choledochoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones. It is typically introduced via a flexible duodenoscope and anatomical images are transmitted to a monitor for viewing typically through a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end. 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207066805NARichard Wolf GmbHFBN2026-06-02
04055207007709NARichard Wolf GmbHFBN2026-05-29
04055207007723RIWORichard Wolf GmbHFBN2026-05-29
04055207007747NARichard Wolf GmbHFBN2026-05-29
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
06973786291396Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2024-09-14
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
06970462546320Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546337Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11