FDA.reportPublic FDA data

Single Use Retrieval Basket V

Primary DI
04953170466168
Brand
Single Use Retrieval Basket V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FG-V432P
Catalog number
N3040340
Published
2025-03-25
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
K243807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243807000Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.2025-03-18LQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170466165PackageGS11In Commercial Distribution
04953170466168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046616514953170466165
04953170466168049531704661684953170466168

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
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900741NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900758NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900796NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900802NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900819NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900826NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664901465NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664901472NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903568NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903575NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903582NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903599NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903605NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903629NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903797NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907597NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907603NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907610NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907627NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664910672NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911310NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911327NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911556NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911563NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911570NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912171NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912188NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912195NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912201NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912218NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03