FDA.reportPublic FDA data

Single-Use Flexible Cystoscope

Primary DI
06972197483109
Brand
Single-Use Flexible Cystoscope
Company
Hunan Vathin Medical Instrument Co., Ltd
Model
CY-S1D00R
Published
2024-01-23
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
K221580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221580000Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.2022-11-18FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26972197483103PackageGS12In Commercial Distribution
56972197483104PackageGS110In Commercial Distribution
06972197483109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697219748310326972197483103
5697219748310456972197483104
06972197483109069721974831096972197483109

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
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
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00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893151Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893168Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893175Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893182Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893199Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893205Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893212Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893229Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893236Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893243Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
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00810143893267Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
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00810143893281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893311Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00848657076609AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076616AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076623AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078412AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078429AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078436AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078443AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085656AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085663AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00810143893007Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-20