FDA.reportPublic FDA data

CelioFlex™ 5 N

Primary DI
03760187912080
Brand
CelioFlex™ 5 N
Company
MAUNA KEA TECHNOLOGIES
Model
FP-10036
Published
2020-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K193416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193416000Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies2020-02-28OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760187912080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760187912080037601879120803760187912080

GMDN Terms#

Term, Definition table
TermDefinition
Confocal endomicroscopy system probeA minimally-invasive distal component of an endomicroscopy system intended to capture real-time images of microscopic cellular and tissue structures during an endoscopic procedure. It is a flexible fibreoptic bundle typically connected to a laser scanning unit that channels a laser beam to the anatomical site of interest and allows visualization by detecting the fluorescence emitted by the cells in the targeted region. This is a reusable device intended to be sterilized or disinfected prior to use.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+33170080967support@maunakeatech.com

Regulatory Flags#

DUNS number
394136118
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760187910055ColoFlex™ UHD211-0134MP-0006-HDC2016-09-24
03760187910079GastroFlex™ UHD211-0072MP-0009-HDG2016-09-24
03760187913001Cellvizio® I.V.E.FP-100012024-02-28
03760187910772AQ-Flex™ 19-C211-0211MP-0023-AQF2023-02-09
03760187912011AlveoFlex™ NFP-100292020-05-15
03760187912028GastroFlex™ NFP-100302020-05-15
03760187912035ColoFlex™ NFP-100312020-05-15
03760187912042CystoFlex™ R NFP-100322020-05-15
03760187912059AQ-Flex™ 19 NFP-100332020-05-15
03760187912073CholangioFlex™ NFP-100352020-05-15
03760187912097UroFlex™ NFP-100372020-05-15
03760187912103CystoFlex™ F NFP-100382020-05-15
03760187912004Cellvizio® I.V.E.FP-100012020-05-15
00827002472693Cellvizio® 100 series (488nm)210-0027CS-100-448-CK-12016-12-12
00827002472716Cellvizio® 100 series (488nm)210-0027CS-100-488-CK-32016-12-12
00827002472730UroFlex™B211-0142MP-0011-URF-CK2016-12-12
00827002472747CystoFlex™F211-0146MP-0012-CYS-CK2016-12-12
00827002472754CystoFlex™UHD R211-0147MP-0013-HCYS-CK2016-12-12
03760187910758CranioFlex™211-0174MP-0021-CRF2018-10-08
03760187910765CranioFlex™-C211-0175MP-0022-CRF2018-10-08

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
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06971679949867Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
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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