Search Results
Found 1 results
510(k) Data Aggregation
K Number
K120821Device Name
LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
Manufacturer
MISDER, LLC
Date Cleared
2012-05-11
(53 days)
Product Code
OCT, GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MISDER, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LLICS™ is indicated for use in laparoscopic surgeries to clean the laparoscope lens within the surgical cavity, preventing temperature changes associated with lens fogging.
Device Description
The LLICS sterile system is intended for single-procedure use. Each LLICS package includes two cleaning swabs that can be introduced through an existing surgical trocar or cannula and one bottle of surfactant.
Each cleaning swab consists of a foam tip mounted on a plastic rod, an outer cannula, and an actuator handle.
The surfactant is applied to the foam tip on the cleaning swab. The tip is then retracted into the LLICS cannula before it is introduced through the surgical trocar/cannula. The LLICS cannula helps to keep the foam tip clean while it passes through the existing surgical trocar/cannula.
Once the LLICS device has passed through the surgical trocar/cannula, the surgeon visualizes the end of the LLICS cannula and uses the actuator handle to deploy the surfactant-moistened foam tip. The actuator handle remains outside the body and can be operated with one hand. The surgeon uses the foam tip to clean the endoscope lens and then retracts the tip into the LLICS cannula. The retracted device can be left in the surgical trocar/cannula for additional cleaning cycles or removed to make the trocar/cannula available for introducing other endoscope accessories.
Ask a Question
Page 1 of 1