SmartBand EMR Kit

Basic Information

• Brand Name: SmartBand EMR Kit
• Primary DI: 00724995247317
• Version / Model: SBEMRK94
• Catalog Number: SBEMRK94
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-21
• Public Version: 1
• Public Version Date: 2025-12-01
• Public Version Status: New
• Public Device Record Key: 6ec703f7-fb9c-4cac-b15e-255f4e725bce

Device Description

The SmartBand EMR Kit 9.4mm is indicated for endoscopic mucosal resection in the upper GI tract.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDI	SNARE, FLEXIBLE	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61613	Endoscopic electrosurgical mucosal biopsy/resection set	A collection of devices designed to be used during an endoscopic mucosal tissue biopsy and/or therapeutic resection procedure to: 1) isolate a specified section of mucosa using endoscopic suction and application of ligature bands; and 2) resect the lesion using monopolar electrosurgical energy. It consists of a ligation unit with distally-mounted bands and a flexible electrosurgical snare. Suction is applied to retract the tissue into the ligator cap, the ligature band(s) are then deployed, followed by electrosurgical resection of the tissue with the snare. Disposable devices for histological sample processing (e.g., biowraps) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995247317	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212860	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			EMR Hexagonal Snare Width 15mm
Device Size Text, specify			9.4 mm barrel tip diameter
Device Size Text, specify			EMR Hexagonal Snare Length 230cm