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510(k) Data Aggregation
K Number
K171637Device Name
OpClear System
Manufacturer
Cipher Surgical Ltd
Date Cleared
2018-02-26
(269 days)
Product Code
OCX, FEQ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Cipher Surgical Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OpClear® System consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions such as condensation, blood and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site.
Device Description
OpClear® System is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens. Consisting of a reusable control unit and a range of sterile, invasive, single use disposables, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures.
OpClear® System is composed of a control unit and a range of disposable accessories as shown below.
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