FDA grants 510(k)approval for TJF-Q190V duodenoscope.- Olympus Medical

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced the FDA clearance of its TJF-Q190V duodenoscope with a sterile, disposable distal endcap. This newest generation of Olympus duodenoscope incorporates innovative features designed to improve the cleaning and reprocessing of the duodenoscope, thereby helping to reduce potential device contamination. The TJF-Q190V duodenoscope responds to the FDA's call for duodenoscopes with disposable components that improve access to the elevator mechanism for ease of reprocessing.. The TJF-Q190V duodenoscope addresses the clinical needs of physicians. Recent statements from medical societies regarding duodenoscope reprocessing and infection control clearly reinforce the need to be able to offer the potentially lifesaving ERCP (endoscopic retrograde cholangiopancreatography) procedure to treat seriously ill patients, rather than more invasive options, such as surgery. The performance of the duodenoscope is critical to reaching difficult-to-access digestive system anatomy. The advanced features of the TJF-Q190V include an expanded field of view, reliable guidewire locking, and more precise handling.