Search Results
Found 1 results
510(k) Data Aggregation
K Number
K964561Device Name
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
Manufacturer
BIOENTERICS CORP.
Date Cleared
1997-02-11
(90 days)
Product Code
FDG
Regulation Number
876.4530Why did this record match?
Product Code :
FDG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENDOLUMINA® II Transillumination System is a medical device designed to aid in the identification of the esophagus, rectum, and other structures by transillumination during laparoscopy, thoracoscopy, or open procedures.
Device Description
The ENDOLUMINA II Transillumination System (EIB II) consists of a glass fiberoptic bundle inserted into a length of silicone elastomer tubing in a configuration similar to a fiberoptic cable. Attached to the cable's proximal end is a ball-shaped fitting which allows a clear, flexible, and detachable silicone tip to be attached or removed by means of a "pop-fit" connection. This tip is available in both blunt and tapered configurations. The EIB II is available in sizes ranging from 4 to 60 Fr. A light source connector/fitting is permanently attached to the distal end of the cable and is designed to be inserted into a commercially-available light source. Light generated from the light source is transmitted through the cable's fiberoptic bundle and down into the clear silicone tip, where it is deflected radially to enhance transillumination. The EIB II is supplied with one (1) cable assembly, which is supplied nonsterile and is designed to be reusable by the customer. Instructions for methods for cleaning and sterilizing the EIB II cable assembly are provided. The EIB II also contains three (3) detachable tips which are individually packaged in a double pouch system and labeled as sterile and for single use only.
Ask a Question
Page 1 of 1