FDA.reportPublic FDA data

invendoscope

Primary DI
04260444390112
Brand
invendoscope
Company
invendo medical GmbH
Model
SC210
Published
2018-06-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K173085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173085000invendoscopy E210 SystemInvendo Medical GmbH2018-01-08FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260444390129PackageGS15Not in Commercial Distribution
04260444390112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260444390129042604443901294260444390129
04260444390112042604443901124260444390112

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video colonoscope, single-useAn 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 typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
333191497
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260444390051invendo ScopeControllerSCCV12016-09-22
04260444390075invendo SPU Processing UnitE2102018-06-29
04260444390082invendo SPU Power UnitE2102018-06-29
04260444390013invendoscope SC2002016-09-22
04260444390037invendo SPU Processing UnitE200 2016-09-22
04260444390044invendo SPU Power UnitE2002016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
04547410566253FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410477245FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477276FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477306FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04953170423628GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04953170454356DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-13
04953170454271DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454288DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454295DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454301DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454325DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454349DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170463914BALLOON3OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-02-25
00850458007157GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16