FDA.reportPublic FDA data

Disposable Biopsy Valve

Primary DI
06970900850934
Brand
Disposable Biopsy Valve
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-BV-O-EO
Published
2023-10-19
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

Product Codes#

Code, Name table
CodeName
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220210000Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-17ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970900850934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970900850934069709008509346970900850934

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic biopsy valve, single-useA device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544375774
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
06936603211571Disposable Polypectomy SnareFTL-PS-24-230-30-M-NSMO-E24-6-12-30-2302026-10-25
06936603211588Disposable Polypectomy SnareFTL-PS-24-230-30-ACM-NSMO-EA24-6-12-30-2302026-10-25
06936603211595Disposable Polypectomy SnareFTL-PS-24-230-30-M-RSMO-24-6-12-30-2302026-10-25
06936603211618Disposable Polypectomy SnareFTL-PS-24-230-30-MT-RSMO-T24-6-12-30-2302026-10-25
06936603211663Disposable Polypectomy SnareFTL-PS-24-230-10-O-RSOV-DR-24-10-2302026-10-25
06936603211670Disposable Polypectomy SnareFTL-PS-24-230-15-O-RSOV-DR-24-15-2302026-10-25
06936603211687Disposable Polypectomy SnareFTL-PS-24-230-20-O-RSOV-DR-24-20-2302026-10-25
06936603211694Disposable Polypectomy SnareFTL-PS-24-230-25-O-RSOV-DR-24-25-2302026-10-25
06936603211700Disposable Polypectomy SnareFTL-PS-24-230-30-O-RSOV-DR-24-30-2302026-10-25
06936603211731Disposable Polypectomy SnareFTL-PS-24-230-15-O-NSOV-DS-23-15-2302026-10-25
06936603211748Disposable Polypectomy SnareFTL-PS-24-230-20-O-NSOV-DS-23-20-2302026-10-25
06936603211755Disposable Polypectomy SnareFTL-PS-24-230-25-O-NSOV-DS-23-25-2302026-10-25
06936603211779Disposable Polypectomy SnareFTL-PS-24-230-35-O-NSOV-DS-23-35-2302026-10-25
06936603216187Kirei FlowFTL-VS-O-HVS-KIT-07-OLY2026-10-25
06936603218259CO2 AdapterFTL-EFC-O-COAD-CO2-OUS2026-10-25
06936603235508CO2 AdapterFTL-EFC-O-CORAD-CO2-OUS-R2026-10-25
06936603211625Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-RCPS-CR-24-02-10-2302026-10-22
06936603211649Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-NCPS-CS-24-02-10-2302026-10-22
06936603211724Disposable Polypectomy SnareFTL-PS-24-230-10-O-NSOV-DS-23-10-2302026-10-22
06936603211908Disposable Biopsy ForcepsFTL-BF-18-180-O-O-RTC11-ECO-S-18-180-SU2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603216187Kirei FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-25
06936603216200Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216224Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216231Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216248Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
06936603216262Kashikoi FlowYangzhou Fartley Medical Instrument Technology Co., LtdODC2026-10-22
00850025860970Endoscopy Kit - Basic Aux HBMicro-tech UsaODC2026-10-12
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONODC2026-08-25
06973141950845EndocleanChangzhou Endoclean Medical Device Co.,LtdODC2026-07-16
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
00724995246693DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246709DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246716DEFENDO Biopsy Valve IrrigatorMEDIVATORS INC.ODC2026-04-06
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246846DEFENDO SINGLE USE VALVE KITMEDIVATORS INC.ODC2026-04-06
00724995247300NAMEDIVATORS INC.ODC2026-03-02
04897106957835Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957576andorate® Champion 3-piece Valve KitGA Health Company LimitedODC2025-11-21
04897106957583andorate® Champion 4-piece valve kitGA Health Company LimitedODC2025-11-21
04897106957644Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2025-10-30