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510(k) Data Aggregation
K Number
K231622Device Name
REGER Nebulizer Irrigation Cannula
Manufacturer
Date Cleared
2023-09-29
(119 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
REGER Medizintechnik, GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The REGER Nebulizer Irrigation Cannula is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.
Device Description
The REGER Medizintechnik Nebulizer Irrigation Cannula is a sterile, single use stainless steel cannula with a polymer handle that is intended to nebulize irrigation fluids into the body during laparoscopic procedures. The sterile irrigation fluid is delivered from an injection pump (not provided) through the polymer tubing and into the stainless-steel shaft. The shaft has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The REGER Medizintechnik Nebulizer Irrigation Cannula is designed with a precision orifice at the tip for the deployment of a precise nebulized spray of irrigation solution into the laparoscopic cavity.
The REGER Medizintechnik Nebulizer Irrigation Cannula is straight and measures between 243-245 mm from Tip to the end of the handle with a shaft diameter ranging from 3.0 - 8.0 mm. The orifice at the head of the cannula shaft ranges in diameter of 0.17mm to 0.2mm. The REGER Medizintechnik Nebulizer Irrigation Cannula also contains a 10' flexible 3.15mm outer diameter polymer tube at the handle end for attachment to attached to irrigation fluid injection pump (not provided) via a luer fitting.
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