FDA.reportPublic FDA data

Disposable Polypectomy Snare

Primary DI
06936603211670
Brand
Disposable Polypectomy Snare
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-PS-24-230-15-O-R
Catalog number
SOV-DR-24-15-230
Device description
Disposable Polypectomy Snare, hot snare, OD 2.4 mm, loop opening 15 mm, working length 230 cm, oval, rotatable
Published
2026-10-25
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

Product Codes#

Code, Name table
CodeName
FDISnare, Flexible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220790000Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-27FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936603211677PackageGS110In Commercial Distribution
26936603211674PackageGS110In Commercial Distribution
06936603211670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660321167716936603211677
2693660321167426936603211674
06936603211670069366032116706936603211670

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Regulatory Flags#

DUNS number
544375774
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
false
Sterilization required before use
false

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
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
06936603211953Disposable Biopsy ForcepsFTL-BF-30-230-O-O-RTC11-ECO-30-230-SU2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603211571Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211588Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211595Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211618Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211663Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211687Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211694Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211700Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211731Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211748Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211755Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211779Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211724Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-22
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