FDA.reportPublic FDA data

Single Use Retrieval Basket V

Primary DI
14953170466141
Brand
Single Use Retrieval Basket V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FG-V422PR
Catalog number
N3040140
Published
2025-03-25
Public version status
New
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
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
14953170466141PackageGS11In Commercial Distribution
04953170466144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046614114953170466141
04953170466144049531704661444953170466144

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.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900741NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
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06959664900826NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
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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
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06959664907603NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
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06959664907627NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
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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