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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 is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device. FDA UDI
Model / Reference
00711085 FDA UDI
Description
The iSnare system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device. FDA UDI

Identifiers

Catalog Number
00711085 FDA UDI
Primary DI / UDI-DI
00724995180799 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
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
Needle Gauge — 23 Gauge FDA UDI
Width — 2.5 Millimeter FDA UDI
Length — 230 Centimeter FDA UDI

Category: Endoscopic electrosurgical submucosal lift/resection set

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

Similar devices

Also classified as Endoscopic electrosurgical submucosal lift/resection set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endoscopy

Sources (1)

  • FDA UDI f912c139-47d6-4c4d-b8ba-b7bb235e0676 37 fields · synced May 30, 2026