FDA.reportPublic FDA data

Saneso

Primary DI
G347SAN1GA0
Brand
Saneso
Company
Saneso Inc.
Model
SAN1G-A
Device description
Saneso Single Camera Gastroscope with high definition imaging, 140-160 degree FOV, lens wash system, dedicated tissue wash system, LED lighting, select band imaging, a vertical & horizontal bending radius of 180 & 160 degrees.
Published
2022-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210052000Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))Saneso, Inc.2022-04-01FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G347SAN1GA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video gastroscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1040Millimeter
Outer Diameter11.6Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6812984613koushik.garapati@saneso.com

Regulatory Flags#

DUNS number
117059270
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G347SAN1CA0SanesoSAN1C-A2022-11-11
G347SBA0SanesoG347SBA2022-11-11
G347SAN360CA0SanesoSAN360C-A2022-11-04
G347SAN360GA0SanesoSAN360G-A2022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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