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The Stryker Ureteroscope is indicated for use during minimally invasive urological surgical procedures accessed through natural body orifices, and is intended for, but not limited to, transurethral examination of the urinary tractures and, utilizing additional accessories, to perform various diagnostic and therapeutic procedures.

The Stryker Ureteroscope is a new product developed by Stryker. The Stryker Ureteroscope is a new product and polymers.

The provided text is a 510(k) summary for the Stryker Ureteroscope and the associated FDA clearance letter. It does not describe any acceptance criteria or a study proving that the device meets those criteria.

The 510(k) summary focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting performance data against defined acceptance criteria.

Therefore, I cannot provide the requested information from the given input. The document explicitly states:

• "There are no significant technological or performance differences between the Stryker Ureteroscope and the identified predicate device, nor are there any new questions raised Ureteroscope and the luentified produce the Stryker Ureteroscope is substantially equivalent to the identified predicate device."

This indicates that the submission relies on the predicate device's established safety and effectiveness, rather than new performance studies of the Stryker Ureteroscope against specific criteria.

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