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510(k) Data Aggregation
K Number
K102452Device Name
DEFOGGING AND CLEANING SOLUTION- FLO-X
Manufacturer
MINIMALLY INVASIVE DEVICES LLC
Date Cleared
2010-12-23
(118 days)
Product Code
OCT
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MINIMALLY INVASIVE DEVICES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.
Device Description
The Minimally Invasive Defogging and Cleaning Solution is a biocompatible surfactant (Docusate Sodium) when used as indicated. It functions in the same manner as the predicate devices. It is intended to be used to prevent fogging of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries. Additionally, the solution can be used to clean the end of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries (i.e. to rinse lens intra-operatively by rinsing any debris from the lens which becomes attached to the lens as a result of the procedure.)
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K Number
K080613Device Name
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
Manufacturer
MINIMALLY INVASIVE DEVICES LLC
Date Cleared
2008-11-06
(247 days)
Product Code
OCT, GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MINIMALLY INVASIVE DEVICES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clear-Vu System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.
Device Description
The Clear-Vu System consists of a multi-lumen sheath assembly mounted on the shaft of the laparoscope, which connects to the existing CO₂ insufflation circuit to defog the laparoscope lens and divert surgical debris, and connects to the existing surgical irrigation system to clean the lens via saline flush.
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