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510(k) Data Aggregation
K Number
K113697Device Name
EIGR SURGICAL ILLUMINATION SYSTEM
Manufacturer
INVUITY, INC.
Date Cleared
2012-02-10
(56 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
INVUITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Invuity® Eigr™ Surgical Illumination System is intended to provide surgical site illumination from a high intensity light source.
Device Description
Not Found
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K Number
K090070Device Name
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
Manufacturer
INVUITY, INC.
Date Cleared
2009-04-22
(100 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
INVUITY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Invuity BriteField™ McCulloch Retractor System is intended to provide surgical site illumination from a high intensity light source.
Device Description
The Invuity BriteField™ McCulloch Retractor System is a blade-based retraction system designed to provide surgeons with the ability to retract tissue through any combination of blades and hooks, when these devices are assembled onto a retractor frame. The Invuity BriteField™ McCulloch Retractor System is similar in design and function to current existing McCulloch Retractor Systems (Class I Exempt) with the exception that it features optional accessory illumination devices (waveguides) that can be attached to the Invuity BriteField" McCulloch Retractor System's blades and hooks. The BriteField McCulloch Waveguides are designed to deliver light from any hospitalprovided ACMI compatible 300-watt surgical light source via fiber optic cables to a targeted output area in the surgical field. BriteField McCulloch Retractor components and fiber optic cables of the Invuity BriteField™ McCulloch Retractor System are. reusable and supplied non-sterile: BriteField McCulloch Waveguides are single-use devices which are provided sterile.
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