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iSnare

FDA UDI

Class II (US FDA UDI)

by US Endoscopy

Identity

Trade Name
iSnare FDA UDI
Generic Name
Endoscopic electrosurgical submucosal lift/resection set FDA UDI
Device Name
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. FDA UDI
Model / Reference
00711084 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
00711084 FDA UDI
Primary DI / UDI-DI
00816765012741 FDA UDI
510(k) Number
K152035 FDA UDI
FDA Product Code
FBK FDA UDI
FDI FDA UDI
GMDN Term
Endoscopic electrosurgical submucosal lift/resection set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
876.4300 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.5 Millimeter FDA UDI
Length — 230 Centimeter FDA UDI
Width — 30 Millimeter FDA UDI
Needle Gauge — 25 Gauge FDA UDI

iSnare by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endoscopy

Sources (1)

  • FDA UDI 5695a50d-b8ab-4f83-9e1b-7f2f1eb2f0dc 39 fields · synced May 30, 2026