FDA.reportPublic FDA data

Non-ICG 4mm Sinuscope (0 Deg)

Primary DI
G465FG15000
Brand
Non-ICG 4mm Sinuscope (0 Deg)
Company
Smartsurgn Inc.
Model
FG-15
Device description
Non-ICG 4mm Sinuscope (0 Deg)
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032822000ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0Asap Endoscopic Products GmbH2004-01-08EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G465FG15000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical sinoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user through relayed lens optics or a 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
G465FG13240Light CableFG 13242024-07-17
G465FG12000Non-ICG 4mm Sinuscope (70 Deg)FG-122025-08-27
G465FG14000Non-ICG 4mm Sinuscope (30 Deg)FG-142025-08-27
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
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04953170467592DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04961333255238VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255306VIVIDEOHOYA CORPORATIONEOB2025-12-19
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.EOB2024-11-14
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00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
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06970462546443Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546191Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
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00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22