FDA.reportPublic FDA data

Saneso

Primary DI
G347SAN360CA0
Brand
Saneso
Company
Saneso Inc.
Model
SAN360C-A
Device description
Saneso Colonoscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle lens wash system, dedicated tissue wash system, LED lighting, select band and dual band imaging, vertical & horizontal bending radius of 180 degrees & 160 degrees, preserved mechanical characteristics, and a continuous guide view™ of the lumen.
Published
2022-11-04
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
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope 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
G347SAN360CA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video colonoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1680Millimeter
Outer Diameter15.6Millimeter

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
G347SAN1GA0SanesoSAN1G-A2022-11-11
G347SBA0SanesoG347SBA2022-11-11
G347SAN360GA0SanesoSAN360G-A2022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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