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The TUNIS™ probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection procedures. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary tract.

TUNIS™ - Transurethral Injection System Probe/Device

This document is a 510(k) clearance letter from the FDA for a medical device called the "Tunis™ Transurethral Injection/Aspiration System Probe Device." It signifies that the device has been found substantially equivalent to a predicate device and can be marketed.

Crucially, this document does not contain information about acceptance criteria, device performance details, or any study results proving the device meets acceptance criteria.

The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, ensuring similar safety and effectiveness. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a pre-market approval (PMA) would for novel, high-risk devices.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the original 510(k) submission document (K983765) itself, which might contain summaries of performance testing, albeit less rigorous than what's typically expected for a PMA.

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