FDA.reportPublic FDA data

VIDEO CYTOSCOPE

Primary DI
04961333232413
Brand
VIDEO CYTOSCOPE
Company
PENTAX OF AMERICA, INC.
Model
ECY-P1570K
Device description
VIDEO CYSTOSCOPE (REFURBISHED)
Published
2017-04-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K914008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914008000PENTAX CYSTOFIBERSCOPE, MODEL FCY-15PPentax Precision Instrument Corp.1992-01-10FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333232413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333232413049613332324134961333232413

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, reusableAn 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 reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""High-level Disinfectant""]"
Ethylene Oxide;High-level Disinfectant

Regulatory Flags#

DUNS number
083211284
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926952PENTAX MedicalPENTAX MEDICAL CORPORATIONFAJ2026-08-25
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
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