FDA.reportPublic FDA data

Light Cable

Primary DI
G465FG13240
Brand
Light Cable
Company
Smartsurgn Inc.
Model
FG 1324
Device description
Schott Fiber Optic Light Cable
Published
2024-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213943000SmartSurgN Visualization SystemSmartsurgn Incorporated2022-11-29OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G465FG13240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
115617378
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G465FG12000Non-ICG 4mm Sinuscope (70 Deg)FG-122025-08-27
G465FG14000Non-ICG 4mm Sinuscope (30 Deg)FG-142025-08-27
G465FG15000Non-ICG 4mm Sinuscope (0 Deg)FG-152025-08-27
G465FG16000Non-ICG 5mm Laparoscope (0 Deg)FG-162025-08-27
G465FG17000Non-ICG 5mm Laparoscope (30 Deg)FG-172025-08-27
G465100300AirSurgN Insufflator100302025-04-22
G465FG1800Monitor 55 InchFG-182025-03-13
G465FG11220OptIcSurgNFG11222024-01-30
G465FG11230OptIcSurgNFG11232024-01-30
E30000019EyeRSurgN100102023-11-20
G465FG13140View4SurgNFG13142023-10-20
G465100100EyeRSurgN100102023-10-16
G465100200IRLightSurgN100202023-10-16
G465100400PrizMCurgN100402023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403001ActivSight Light EngineActiv Surgical, Inc.OWN2026-05-26
00850016403018Activ Sight C-Mount Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403025ActivSIght Light GuideActiv Surgical, Inc.OWN2026-05-26
00850016403032ActivSight Light Cable Adapter - StrykerActiv Surgical, Inc.OWN2026-05-26
00850016403087ActivSight Light Cable Adapter - StorzActiv Surgical, Inc.OWN2026-05-26
00850016403094ActivSight Integrated Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRActiv Surgical, Inc.OWN2026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRActiv Surgical, Inc.OWN2026-05-26
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-11-21
06971679949782Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949799Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949805Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949812Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949829Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949836Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949843Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949850Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949867Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949874Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949881Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949898Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949904Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949911Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949928Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949935Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
04048551418123n.a.Karl Storz GmbH & Co. KGOWN2025-08-11
04250480104200NASCHÖLLY FIBEROPTIC GmbHOWN2025-06-11
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17