FDA.reportPublic FDA data

Single-Use Cystoscope

Primary DI
06970462546269
Brand
Single-Use Cystoscope
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
CY-M32
Published
2024-06-11
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
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231118000Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2023-11-13FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970462546266PackageGS110Not in Commercial Distribution
26970462546263PackageGS15Not in Commercial Distribution
06970462546269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697046254626616970462546266
2697046254626326970462546263
06970462546269069704625462696970462546269

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, single-useA sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.

Regulatory Flags#

DUNS number
403655303
Device count
1
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
06979988682000Single-Use UreterorenoscopeHU30S-V2026-07-25
06979988682017Single-Use UreterorenoscopeHU30M-V2026-07-25
06979988682024Single-Use UreterorenoscopeHU30SC-V2026-07-25
06979988682031Single-Use UreterorenoscopeHU30SC2026-07-25
06970462547334HueRex™ Disposable Stone Retrieval BasketBS-3P-5312/082026-07-11
06970462547341HueRex™ Disposable Stone Retrieval BasketBS-3P-5312/112026-07-11
06970462547358HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/082026-07-11
06970462547365HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/112026-07-11
06970462547372HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/082026-07-11
06970462547389HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/112026-07-11
06970462547396HueRex™ Disposable Stone Retrieval BasketBS-4P-0612/102026-07-11
06970462547402HueRex™ Disposable Stone Retrieval BasketBS-4P-0612/162026-07-11
06970462546771Single-use Ureteral Access SheathY-10-502025-07-23
06970462546788Single-use Ureteral Access SheathY-11-402025-07-23
06970462546795Single-use Ureteral Access SheathY-11-502025-07-23
06970462546801Single-use Ureteral Access SheathY-12-402025-07-23
06970462546818Single-use Ureteral Access SheathY-12-502025-07-23
06970462547457Single-use Ureteral Access SheathY-08-362026-02-10
06970462547464Single-use Ureteral Access SheathY-08-402026-02-10
06970462547471Single-use Ureteral Access SheathY-08-452026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140603WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140610AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140627AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140665WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140672WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140689WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140696WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21