FDA.reportPublic FDA data

iSnare

Primary DI
00816765012741
Brand
iSnare
Company
US Endoscopy
Model
00711084
Catalog number
00711084
Device description
The iSnare system–Lariat snare is used to inject various types of media and to grasp, dissect and transect tissue during gastrointestinal endoscopy procedures, and can be used with or without monopolar diathermic energy.
Published
2017-02-24
Public version status
Update
Distribution status
Not 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
FBKendoscopic injection needle, gastroenterology-urology
FDISNARE, FLEXIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2
FDISnare, FlexibleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152035000iSnare system-LariatUnited States Endoscopy Group, Inc.2015-10-15FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765012748PackageGS15Not in Commercial Distribution
00816765012741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501274810816765012748
00816765012741008167650127418167650127410816765012741

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length230Centimeter
Needle Gauge25Gauge
Outer Diameter2.5Millimeter
Width30Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

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
06936603211670Disposable 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
06936603212196ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212202ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212219ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212240ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212257ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212271ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212288ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
06936603212295ECO InjectYangzhou Fartley Medical Instrument Technology Co., LtdFBK2026-10-22
10850002461388InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461395InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461418InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
10850002461425InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
06926839809147AnreiAnrei Medical(HZ)Co., Ltd.FBK2025-01-08
06926839809130AnreiAnrei Medical(HZ)Co., Ltd.FBK2025-01-07
06926839809154AnreiAnrei Medical(HZ)Co., Ltd.FBK2025-01-07
06926839809161AnreiAnrei Medical(HZ)Co., Ltd.FBK2025-01-07