FDA.reportPublic FDA data

SmartSnare EMR Hexagonal Snare

Primary DI
00850261006125
Brand
SmartSnare EMR Hexagonal Snare
Company
INTELLIGENT ENDOSCOPY LLC
Model
SS-230-1
Catalog number
SS2301
Device description
SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled rotation designed to facilitate placement around the band.
Published
2022-03-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K212860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212860000SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)STERIS Corporation2021-10-07FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850261006125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850261006125008502610061258502610061250850261006125

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-cutting endoscopic polypectomy snareA sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length230Centimeter
Width15Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(336)608-4375info@intelligentendoscopy.com

Regulatory Flags#

DUNS number
046601986
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850261006200SmartBand EMR PackSBEMRP94SBEMRP942022-03-21
00850261006217SmartBand EMR KitSBEMRK94SBEMRK942022-03-21
00850261006002SmartBand Ligation PackSLP-6IE110012017-08-01
00850261006019SmartBand Ligation KitSLK-6IE110022017-08-01
00850261006033SmartBand SafeGrip Multi-Band Ligation KitSLK-6-LFIE110042017-08-01
00850261006040SmartBand SafeGrip Multi-Band Ligation PackSLP-6-LFIE110032017-08-01
00850261006071SmartBand EMR KitSBEMRKSBEMRK2022-03-21
00850261006088SmartBand EMR PackSBEMRPSBEMRP2022-03-21
00850261006101SmartBand EMR KitSBEMRK12SBEMRK122022-03-21
00850261006118SmartBand EMR PackSBEMRP12SBEMRP122022-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00724995180829iSnareUS EndoscopyFDI2020-03-19
00724995182472Short ThrowUS EndoscopyFDI2020-03-19
00724995182489Short ThrowUS EndoscopyFDI2020-03-19
00724995182496Roth NetUS EndoscopyFDI2020-03-19
00724995182502Roth NetUS EndoscopyFDI2020-03-19
00724995182519Roth NetUS EndoscopyFDI2020-03-19
00724995182526Roth NetUS EndoscopyFDI2020-03-19
00724995182533Roth NetUS EndoscopyFDI2020-03-19
00724995182540Polyp PakUS EndoscopyFDI2020-03-19
00724995182571LariatUS EndoscopyFDI2020-03-19
00724995182588LariatUS EndoscopyFDI2020-03-19
00724995182595Short ThrowUS EndoscopyFDI2020-03-19
00724995182601TraxtionUS EndoscopyFDI2020-03-19
00724995182625HistolockUS EndoscopyFDI2020-03-19