FDA.reportPublic FDA data

Single Use Retrieval Nitinol Basket V

Primary DI
04953170395321
Brand
Single Use Retrieval Nitinol Basket V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FG-V451P
Published
2018-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170811000Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp.2017-11-27LQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170395328PackageGS11In Commercial Distribution
04953170395321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317039532814953170395328
04953170395321049531703953214953170395321

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 open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, 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.

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
06932503511414Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511421Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511438Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511513Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511520Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511537Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511544Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511551Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511568Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511575Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511582Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511599Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511605Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511612Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511629Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511711eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511728eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511735eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511742eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511759eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511766eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511773eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511780eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511797eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511803eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511810eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511827eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511834eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511841eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511858eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28