FDA.reportPublic FDA data

CystoView™

Primary DI
00840432200308
Brand
CystoView™
Company
Verathon Medical (Canada) ULC
Model
Clamp Kit Configuration with Holder and QuickConne
Catalog number
0270-1202
Device description
CystoView™ Clamp Kit Configuration with Holder and QuickConnect™ Cable
Published
2026-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253696000CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) Ulc2026-05-11FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840432200308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840432200308008404322003088404322003080840432200308

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Regulatory Flags#

DUNS number
243738320
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840432200063CystoView™Essential Configuration with Holder and QuickConne0270-12032026-05-15
00840432200117CystoView™CystoView™ Monitor0570-04652026-05-15
00840432200315CystoView™Clamp Kit Configuration with QuickConnect™ Cable0270-12012026-05-15
00840432200322CystoView™Monitor with QuickConnect™ Cable0270-12002026-05-15
00879123006561GlideScope®Video Baton 2.0 Large (3-4)0570-03822022-12-08
00879123007797GlideScope®Video Baton QC Large0570-04172022-12-08
00879123009012BFlex™BFlex™ 2 SamplePro™0574-02632026-05-29
00879123009340GlideScope®GlideScope® Core™ 10 FHD Essential Configuration0270-1212-FHD2026-05-29
00879123009357GlideScope®GlideScope® Core™ 15 FHD Essential Configuration0270-1213-FHD2026-05-29
00840432200056Verathon®Verathon® Essential Workstation0800-07002026-05-28
00840432200001CFlex™Single-Use Cystoscope, Standard Deflection0570-04552026-05-15
00840432200018CFlex™Single-Use Cystoscope, Reverse Deflection0570-04592026-05-15
00879123007841GlideScope®ClearFit™ Video Baton0570-04252025-08-01
00879123008381GlideScope®ClearFit™ Hyperangle 3 Cover0574-02422025-08-01
00879123008398GlideScope®ClearFit™ Hyperangle 4 Cover0574-02432025-08-01
00879123008428GlideScope®ClearFit™ Miller 2 Cover0574-02472025-08-01
00879123008442GlideScope®ClearFit™ MAC 2 Cover0574-02442025-08-01
00879123008459GlideScope®ClearFit™ MAC 3 Cover0574-02452025-08-01
00879123008466GlideScope®ClearFit™ MAC 4 Cover0574-02462025-08-01
00879123007612GlideScope®GlideScope® Go™ 2 Monitor Configuration0270-11862025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170421594HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.FET2026-07-22
04547410480269FUJIFILMFUJIFILM CORPORATIONFET2026-05-22
00840432200063CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200117CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200315CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200322CystoView™Verathon Medical (Canada) ULCFET2026-05-15
04049047788553GimmiGimmi GmbHFET2026-03-04
04049047788577GimmiGimmi GmbHFET2026-03-04
04049047788584GimmiGimmi GmbHFET2026-03-04
06971176282399EviewZhuhai Pusen Medical Technology Co, LtdFET2026-01-22
06972520300677Endoscopic Video Image ProcessorGuangzhou Red Pine Medical Instrument Co., Ltd.FET2025-12-31
05391533810088ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
05391533810095ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.FET2025-11-21
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
04961333255801INSPIRAHOYA CORPORATIONFET2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFET2025-06-20
04250480104200NASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONFET2025-05-31
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170445453OTV-S700 UPGRADE PACK 3DOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04048551432259NAKarl Storz GmbH & Co. KGFET2025-03-27
04049047788539GimmiGimmi GmbHFET2025-03-20
04049047788546GimmiGimmi GmbHFET2025-03-20
04049047788560GimmiGimmi GmbHFET2025-03-20
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FET2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FET2025-02-28