FDA.reportPublic FDA data

F88

Primary DI
08881300750084
Brand
F88
Company
SG ENDOSCOPY PTE. LTD.
Model
0502388100
Catalog number
0502388100
Device description
Flexible Ureteroscope, Standard Deflection
Published
2025-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K243894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243894000F88 URE-SD/RD Flexible UreteroscopeSg Endoscopy Pte, Ltd.2025-05-02FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08881300750084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08881300750084088813007500848881300750084

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video ureteroscope, reusableAn 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 a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the 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 reusable device.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
800-642-4422xx@xx.xx

Regulatory Flags#

DUNS number
595455258
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08881300750107F88050338800105033880012025-06-30
08881300750060F88050338800705033880072025-06-30
08881300750077F88050338800805033880082025-06-30
08881300750091F88050238811005023881102025-06-30
08881300750152F88022838800002283880002025-06-30
08881300750046F88Pkg, Luer Lock Stopcock, Reusable, Female X Male05033880012025-06-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
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00850023925978AptraOtu Medical Inc.FGB2026-07-28
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06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
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06972084140535WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
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06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28