FDA.reportPublic FDA data

Single-Use Flexible Cystoscope

Primary DI
06972197482409
Brand
Single-Use Flexible Cystoscope
Company
Hunan Vathin Medical Instrument Co., Ltd
Model
CY-E2F01
Published
2024-12-30
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
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
K242535000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242535000Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)Hunan Vathin Medical Instrument Co., Ltd.2024-12-18FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972197482406PackageGS11In Commercial Distribution
26972197482403PackageGS12In Commercial Distribution
56972197482404PackageGS110In Commercial Distribution
06972197482409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697219748240616972197482406
2697219748240326972197482403
5697219748240456972197482404
06972197482409069721974824096972197482409

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554484862
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972197483420Single-use Ureteral Access SheathUA-S18022025-08-08
06972197483437Single-use Ureteral Access SheathUA-S18032025-08-08
06972197483444Single-use Ureteral Access SheathUA-S1A022025-08-08
06972197483451Single-use Ureteral Access SheathUA-S1A032025-08-08
06972197483468Single-use Ureteral Access SheathUA-S1B022025-08-08
06972197483475Single-use Ureteral Access SheathUA-S1B032025-08-08
06972197483482Single-use Ureteral Access SheathUA-S1C022025-08-08
06972197483499Single-use Ureteral Access SheathUA-S1C032025-08-08
06972197483505Single-use Ureteral Access SheathUA-S1D022025-08-08
06972197483512Single-use Ureteral Access SheathUA-S1D032025-08-08
06972197482225Single-use Ureteral Access SheathUA-S18002024-11-04
06972197482232Single-use Ureteral Access SheathUA-S18012024-11-04
06972197482249Single-use Ureteral Access SheathUA-S1A002024-11-04
06972197482256Single-use Ureteral Access SheathUA-S1A012024-11-04
06972197482263Single-use Ureteral Access SheathUA-S1B002024-11-04
06972197482270Single-use Ureteral Access SheathUA-S1B012024-11-04
06972197482287Single-use Ureteral Access SheathUA-S1C002024-11-04
06972197482294Single-use Ureteral Access SheathUA-S1C012024-11-04
06972197482300Single-use Ureteral Access SheathUA-S1D002024-11-04
06972197482317Single-use Ureteral Access SheathUA-S1D012024-11-04

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