FDA.reportPublic FDA data

SemiFlex Scope

Primary DI
B324MFENDO600
Brand
SemiFlex Scope
Company
MAXIFLEX, LLC
Model
MF-ENDO 60
Device description
60 centimeter single use endoscope for urological application.
Published
2016-09-24
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
K111480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111480000MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CMTechnology Delivery Systems, Inc.2012-04-04FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B324MFENDO600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic ureteroscopeAn 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 transmitted to the user by the device through a fibreoptic bundle. 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge9.5French
Length60Centimeter

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Regulatory Flags#

DUNS number
198887072
Device count
1
DM exempt
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B324MF1000BH0MaxiFlex Holmium Laser Fiber MF 1000BH 2016-09-24
B324MF1000BHC0MaxiFlex Holmium Laser Fiber MF 1000BH C2016-09-24
B324MF1000BHD0MaxiFlex Holmium Laser Fiber MF 1000BH D2016-09-24
B324MF1000BHN0MaxiFlex Holmium Laser Fiber MF 1000BH N2016-09-24
B324MF1000BHT0MaxiFlex Holmium Laser Fiber MF 1000BH T2016-09-24
B324MF200BHHPX0MaxiFlex Holmium Laser Fiber MF 200BH HPX2016-09-24
B324MF200BHHPXC0MaxiFlex Holmium Laser Fiber MF 200BH HPX C2016-09-24
B324MF200BHHPXD0MaxiFlex Holmium Laser Fiber MF 200BH HPX D2016-09-24
B324MF200BHHPXN0MaxiFlex Holmium Laser Fiber MF 200BH HPX N2016-09-24
B324MF200BHHPXT0MaxiFlex Holmium Laser Fiber MF 200BH HPX T2016-09-24
B324MF400BH0MaxiFlex Holmium Laser Fiber MF 400BH 2016-09-24
B324MF400BHC0MaxiFlex Holmium Laser Fiber MF 400BH C2016-09-24
B324MF400BHD0MaxiFlex Holmium Laser Fiber MF 400BH D2016-09-24
B324MF400BHN0MaxiFlex Holmium Laser Fiber MF 400BH N2016-09-24
B324MF400BHT0MaxiFlex Holmium Laser Fiber MF 400BH T2016-09-24
B324MF600BH0MaxiFlex Holmium Laser Fiber MF 600BH 2016-09-24
B324MF600BHC0MaxiFlex Holmium Laser Fiber MF 600BH C2016-09-24
B324MF600BHD0MaxiFlex Holmium Laser Fiber MF 600BH D2016-09-24
B324MF600BHN0MaxiFlex Holmium Laser Fiber MF 600BH N2016-09-24
B324MF600BHT0MaxiFlex Holmium Laser Fiber MF 600BH T2016-09-24

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