FDA.reportPublic FDA data

Biopsy Valve

Primary DI
04953170061516
Brand
Biopsy Valve
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-579
Device description
MAJ-579 SEMI-DISPOSABLE BIOPSY VALUE
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBNCholedochoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBNCholedochoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912120000URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPEOlympus Corp.1991-08-07FBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170061516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170061516049531700615164953170061516

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic procedure air/water valve, reusableA non-sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;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
Lot or batch
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
04055207066805NARichard Wolf GmbHFBN2026-06-02
04055207007709NARichard Wolf GmbHFBN2026-05-29
04055207007723RIWORichard Wolf GmbHFBN2026-05-29
04055207007747NARichard Wolf GmbHFBN2026-05-29
04055207007792NARichard Wolf GmbHFBN2026-05-29
04055207007815NARichard Wolf GmbHFBN2026-05-29
04055207007839NARichard Wolf GmbHFBN2026-05-29
04055207008409NARichard Wolf GmbHFBN2026-05-29
04055207038505RIWORichard Wolf GmbHFBN2026-05-29
04055207038529RIWORichard Wolf GmbHFBN2026-05-29
04055207038536RIWORichard Wolf GmbHFBN2026-05-29
00850061601001Tangent Digital catheterTangent Endoscopy LLCFBN2026-04-08
06932503571210eyeMAX(TM) PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.FBN2025-04-25
26932503571214eyeMAX(TM) PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.FBN2025-04-25
06973786291563Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2025-03-20
16973786290518Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2025-03-20
06973786291570Flexible Video-CholedochoscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2025-03-19
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2025-02-28
06973786291396Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2024-09-14
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeShanghai SeeGen Photoelectric Technology Co., LtdFBN2024-09-14
04055207038512RIWORichard Wolf GmbHFBN2024-08-19
04055207008607NARichard Wolf GmbHFBN2024-08-19
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCFBN2024-07-22
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546290Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546306Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546313Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546320Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11
06970462546337Single-Use CholedochoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FBN2024-06-11