FDA.reportPublic FDA data

Single Use Retrieval Basket V

Primary DI
14953170244053
Brand
Single Use Retrieval Basket V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FG-V431P
Device description
Single Use Retrieval Basket V
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCZEndoscopic grasping/cutting instrument, non-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955063000OLYMPUS BASKET GRASPERSOlympus America, Inc.1996-01-22OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170244053PackageGS11In Commercial Distribution
04953170244056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317024405314953170244053
04953170244056049531702440564953170244056

GMDN Terms#

Term, Definition table
TermDefinition
Biliary/urinary stone retrieval basket, single-useA flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an endoscopic procedure [e.g., endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
04953170466137Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466144Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466151Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466168Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466134Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466141Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466158Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466165Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
00816207021386EndoTBasketENDO-THERAPEUTICS, INC.OCZ2025-02-26
10816207021383EndoTBasketENDO-THERAPEUTICS, INC.OCZ2025-02-26
04260206311706stentfix OTSC System SetOvesco Endoscopy Usa, Inc.OCZ2024-09-13
00860001219821ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219845ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219852ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219838ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
04055207027820HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207028940HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207028957HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207041130HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028902HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027783HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027790HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027806HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027813HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028858HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028865HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028872HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028889HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028926HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028933HYSAFERichard Wolf GmbHOCZ2023-01-03