FDA.reportPublic FDA data

VIKY

Primary DI
M975AF07011
Brand
VIKY
Company
ENDOCONTROL
Model
AF0701
Published
2016-09-22
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082233000
K122820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082233000VIKYEndocontrol2008-12-18GCJ
K122820000VIKY UPEndocontrol2013-06-18LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M975AF07011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, power-adjustedA device assembly adjusted or stabilized by electrical, electro-pneumatic or pneumatic means, intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33428380801customer.support@endocontrol-medical.com

Regulatory Flags#

DUNS number
290153894
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M975A507011VIKYA507012016-09-22
M975AR09031VIKYAR09032016-09-22
M975AT07011VIKYAT07012016-09-22
M975AV09031VIKYAV09032018-04-05
M975AD09031VIKYAD09032016-09-22
M975AM09031VIKYAM09032016-09-22
M975AV15011VIKYAV15012016-09-22
M975BR07011VIKYBR07012016-09-22
M975BX07011VIKYBX07012016-09-22
M975BX08021VIKYBX08022016-09-22
M975BX09011VIKYBX09012016-09-22
M975CX08071VIKYCX08072016-09-22
M975ECVCS07011VIKYECVCS07012016-09-22
M975GX07011VIKYGX07012016-09-22
M975KX07011VIKYKX07012016-09-22
M975MX07011VIKYMX07012016-09-22
M975MX09011VIKYMX09012016-09-22
M975PU07011VIKYPU07012016-09-22
M975UF07011VIKYUF07012016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210372LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210518LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210587LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210877LaportSejong Medical Co., LtdGCJ2018-04-05
07613327311839Connect OR OSSTRYKER CORPORATIONGCJ2017-06-30
07613327311846Connected OR OSSTRYKER CORPORATIONGCJ2017-06-30
08719324463126symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463133symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463140symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463157symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463164symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
10080196000746MedlineMEDLINE INDUSTRIES, INC.GCJ2016-10-14