FDA.reportPublic FDA data

iSnare

Primary DI
10724995180796
Brand
iSnare
Company
US Endoscopy
Model
00711085
Catalog number
00711085
Device description
The iSnare system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device.
Published
2020-03-19
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
FBKendoscopic injection needle, gastroenterology-urology

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040961000INJECTOR NEEDLE/SNAREUnited States Endoscopy Group, Inc.2004-07-08FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995180796PackageGS15In Commercial Distribution
00816765010914PreviousGS10
00724995180799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518079610724995180796
00816765010914008167650109148167650109140816765010914
00724995180799007249951807997249951807990724995180799

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length230Centimeter
Needle Gauge23Gauge
Width2.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
627879687
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
true
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
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
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
00850002461404InjecSURE ®Carbon Medical Technologies, Inc.FBK2026-04-09
00850002461435InjecSURE®Carbon Medical Technologies, Inc.FBK2026-04-09
03600040326893BoNeeColoplast A/SFBK2025-05-20
03600040974841BoNeeColoplast A/SFBK2025-05-20
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
00816734023365EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023372EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023389EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816734023396EZ-JectDIVERSATEK HEALTHCARE, INC.FBK2024-07-18
00816207021256AcuJect FlexENDO-THERAPEUTICS, INC.FBK2023-07-11
04953170454011Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
04953170454028Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
04953170454035Single Use InjectorOLYMPUS MEDICAL SYSTEMS CORP.FBK2023-04-29
00860008483720Uro-N CystoscopeUROVIU CORP.FBK2022-12-16
00724995219185FastFloUS EndoscopyFBK2022-11-09