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

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical submucosal lift/resection setA collection of devices designed to be used during an endoscopic mucosal resection procedure to: 1) lift a section of diseased mucosa by injection of a submucosal lifting solution; and 2) resect the lesion using monopolar electrosurgical energy; it may in addition include devices designed to perform vacuum elevation of the lesion to supplement submucosal lifting. It includes a submucosal injection needle, an electrosurgical electrode (e.g., polyp snare), and might include additional supportive devices such as a dye spray catheter and endoscope suction cap. This is a single-use device.

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
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00724995180881NAUS EndoscopyFBK2020-04-02
00724995180898NAUS EndoscopyFBK2020-04-02
00724995180904NAUS EndoscopyFBK2020-04-02
00724995180911NAUS EndoscopyFBK2020-04-02
00724995180928NAUS EndoscopyFBK2020-04-02
00724995180935NAUS EndoscopyFBK2020-04-02
00724995180942NAUS EndoscopyFBK2020-04-02
00724995180850ArticulatorUS EndoscopyFBK2020-04-01
00724995180867ArticulatorUS EndoscopyFBK2020-04-01
00724995180874ArticulatorUS EndoscopyFBK2020-04-01
00724995180782iSnareUS EndoscopyFBK2020-03-19
00724995180782iSnareUS EndoscopyFDI2020-03-19
00724995180799iSnareUS EndoscopyFDI2020-03-19
00724995180799iSnareUS EndoscopyFBK2020-03-19
00724995180805iSnareUS EndoscopyFDI2020-03-19
00724995180805iSnareUS EndoscopyFBK2020-03-19
00724995180812iSnareUS EndoscopyFBK2020-03-19
00724995180812iSnareUS EndoscopyFDI2020-03-19
00724995180829iSnareUS EndoscopyFBK2020-03-19
00724995180829iSnareUS EndoscopyFDI2020-03-19
00724995182472Short ThrowUS EndoscopyFDI2020-03-19
00724995182489Short ThrowUS EndoscopyFDI2020-03-19
00724995182496Roth NetUS EndoscopyFDI2020-03-19
00724995182502Roth NetUS EndoscopyFDI2020-03-19
00724995182519Roth NetUS EndoscopyFDI2020-03-19
00724995182526Roth NetUS EndoscopyFDI2020-03-19