FDA.reportPublic FDA data

iSnare

Primary DI
10724995180789
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
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
FDISNARE, FLEXIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10724995180789PackageGS15In Commercial Distribution
00816765012741PreviousGS10
00724995180782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518078910724995180789
00816765012741008167650127418167650127410816765012741
00724995180782007249951807827249951807820724995180782

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
Special Storage Condition, Specify00Keep Dry

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
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
00724995247317SmartBand EMR KitUS EndoscopyFDI2025-11-21
00724995247324SmartBand EMR PackUS EndoscopyFDI2025-11-21
00724995220051Roth NetUS EndoscopyFDI2024-11-25
00724995220068Roth Net PlatinumUS EndoscopyFDI2024-11-25
00724995194369CoinTipUS EndoscopyFDI2020-06-11
00724995194376CoinTipUS EndoscopyFDI2020-06-11
00724995194383CoinTipUS EndoscopyFDI2020-06-11
00724995182878HistolockUS EndoscopyFDI2020-04-02
00724995182908Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182915Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182922Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182939Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995180782iSnareUS EndoscopyFDI2020-03-19
00724995180799iSnareUS EndoscopyFDI2020-03-19
00724995180805iSnareUS EndoscopyFDI2020-03-19
00724995180812iSnareUS EndoscopyFDI2020-03-19