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SmartBand EMR Kit

FDA UDI

Class II (US FDA UDI)

by Intelligent Endoscopy

Identity

Trade Name
SmartBand EMR Kit FDA UDI
Generic Name
Endoscopic electrosurgical mucosal biopsy/resection set FDA UDI
Device Name
The SmartBand EMR Kit (9.4mm) is indicated for endoscopic mucosal resection in the upper GI tract. FDA UDI
Model / Reference
SBEMRK94 FDA UDI
Description
The SmartBand EMR Kit (9.4mm) is indicated for endoscopic mucosal resection in the upper GI tract. FDA UDI

Identifiers

Catalog Number
SBEMRK94 FDA UDI
Primary DI / UDI-DI
00850261006217 FDA UDI
510(k) Number
K212860 FDA UDI
FDA Product Code
FDI FDA UDI
GMDN Term
Endoscopic electrosurgical mucosal biopsy/resection set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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

Category: Endoscopic electrosurgical mucosal biopsy/resection set

SmartBand EMR Kit by Intelligent Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical mucosal biopsy/resection set.

Cleared under the same submission

K212860 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intelligent Endoscopy

Sources (1)

  • FDA UDI 62994800-925d-4bc7-8c90-2e4f3f766111 37 fields · synced Jun 8, 2026