FDA.reportPublic FDA data

STOPPER

Primary DI
04953170165740
Brand
STOPPER
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-961
Published
2021-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDAEnteroscope And Accessories
PGUSpatial Imaging For Display Of Endoscope Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2
PGUSpatial Imaging For Display Of Endoscope PositionGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002749000ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13DThe Olympus Optical Co.2000-12-04FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170165740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170165740049531701657404953170165740

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783012415Premier Jackson Improved Short Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYFDA2026-06-10
00860014745003FUJIFILM Stiffening Wire (SW-2000)Fujifilm Healthcare Americas CorporationFDA2025-12-18
04547410491715FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
04547410514056FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410491712FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410514053FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
10197106523643CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
50197106523641CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
10197106447185CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
50197106447183CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
10860006600805AncoraAspero Medical, Inc.FDA2023-10-26
00847627004703CD138 + Cyclin D1BIOCARE MEDICAL LLCFDA2023-06-21
04547410467284FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410324280FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410467260FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
14547410467281FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410463439FUJIFILMFUJIFILM CORPORATIONFDA2022-01-30
04953170165801HANGER ADAPTER SETOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-17
04953170165801HANGER ADAPTER SETOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165825PROBE ARM SET AOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-17
04953170165825PROBE ARM SET AOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165849PROBE ARM SET BOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165849PROBE ARM SET BOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-17
04953170077722LCD Monitor Cable AOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170077746Reference Plate CoverOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170077753External Marker Cover BOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170077760External Marker Cover AOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170077777SPARE FUSEOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16
04953170165757WATER RESISTANT CAPOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165757WATER RESISTANT CAPOLYMPUS MEDICAL SYSTEMS CORP.PGU2021-12-16