FDA.reportPublic FDA data

Tangent Digital catheter

Primary DI
00850061601001
Brand
Tangent Digital catheter
Company
Tangent Endoscopy LLC
Model
tng-4002-ind
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K251170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251170000Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital ControllerTangent Endoscopy, LLC2025-09-12FBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061601001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061601001008500616010018500616010010850061601001

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic choledochoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). It is inserted into the body through an artificial orifice created by an incision in the abdomen (laparoscopic technique), or introduced via a flexible duodenoscope during choledochoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures of the CBD and for the removal of stones. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
119478468
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06970462546344Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546351Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546191Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
16970462546303Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
16970462546310Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
16970462546327Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
16970462546334Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
16970462546341Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
16970462546358Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970034210550InnovexShanghai AnQing Medical Instrument Co., LtdFBN2023-11-07
06970034210567InnovexShanghai AnQing Medical Instrument Co., LtdFBN2023-11-07
06970462546146Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2023-09-14