(50 days)
The Coaxial Accordion Stone Management Device Urological is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.
The Coaxial Accordion Stone Management Device consists of a film membrane attached onto a cannula with a removable handle.
The provided text mentions "Performance Data: Not required" for the Coaxial Accordion Stone Management Device. This implies that no specific performance study with acceptance criteria was conducted or necessary for its 510(k) clearance based on substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information as it is not present in the given document. The device received clearance based on its "same intended use, indications for use, and principles of and very similar technological characteristics as the predicate devices."
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.