FDA.reportPublic FDA data

Single Use Retrieval Basket V

Primary DI
04953170466151
Brand
Single Use Retrieval Basket V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FG-V431P
Catalog number
N3040240
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
14953170466158PackageGS11In Commercial Distribution
04953170466151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046615814953170466158
04953170466151049531704661514953170466151

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
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
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

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