FDA.reportPublic FDA data

OES CYSTONEPHROFIBERSCOPE

Primary DI
04953170339417
Brand
OES CYSTONEPHROFIBERSCOPE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS CYF-5
Device description
CYF-5 Flex CystoNephro Fiberscope
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAJCystoscope and accessories, flexible/rigid
FCLFORCEPS, BIOPSY, NON-ELECTRIC
FDISNARE, FLEXIBLE
FGAKit, nephroscope
KGEFORCEPS, BIOPSY, ELECTRIC
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1
FDISnare, FlexibleGastroenterology, Urology2
FGAKit, NephroscopeGastroenterology, Urology2
KGEForceps, Biopsy, ElectricGastroenterology, Urology2
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032092000OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEOlympus Optical Co., Ltd.2003-07-16FCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170339417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170339417049531703394174953170339417

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic cystonephroscopeAn endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. It is inserted into the urethra through the natural urinary orifice, and percutaneously into the renal pelvis for the kidneys during an endoscopic procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal/crushing of stones, pyelitis, and renal failure (nephroscopy); and treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence (cystoscopy). This is a reusable device.

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909424502SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424519SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424526SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424533SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424540SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424557SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08051887049837THD BIOPSYTHD SPAFCL2026-01-07
08051887049851THD BIOPSYTHD SPAFCL2026-01-07
08051887049875THD BIOPSYTHD SPAFCL2026-01-07
08051887043569THD BIOPSYTHD SPAFCL2025-02-20
08051887045754THD BIOPSYTHD SPAFCL2025-02-20
08051887047413THD BIOPSYTHD SPAFCL2025-02-20
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
07898506815296QuinelatoSchobell Industrial LtdaFCL2023-01-09
07898506813018QuinelatoSchobell Industrial LtdaFCL2022-12-08
06932503540353Disposable Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.FCL2020-03-23
06932503540360Disposable Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.FCL2020-03-23
06932503540377Disposable Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.FCL2020-03-23
06932503540384Disposable Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.FCL2020-03-23
08714729019060Active CordBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729053361Active CordBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729056492Injection Gold ProbeBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729056508Injection Gold ProbeBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729099574Gold Probe 350cmBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729174684Gold ProbeBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729174691Gold ProbeBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729251903Ultratome RXBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729251927Ultratome RXBOSTON SCIENTIFIC CORPORATIONKNS2016-09-24
08714729302599PiranhaBOSTON SCIENTIFIC CORPORATIONFCL2016-09-24