FDA.reportPublic FDA data

SemiFlex Scope

Primary DI
B324MFENDO60EA10
Brand
SemiFlex Scope
Company
MAXIFLEX, LLC
Model
MF-ENDO 60 E A1
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
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
B324MFENDO60EA10PrimaryHIBCC0

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
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06972084140535WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140542WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
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06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140757WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140764WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140771WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140788WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140795AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140801AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06979988682000Single-Use UreterorenoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FGB2026-07-25
06979988682017Single-Use UreterorenoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FGB2026-07-25