(43 days)
Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG)procedures), and saphenous vein harvesting.
The devices are separated into several groups: endoscopes, endoscopic needle holders, endoscopic graspers and clamps, endoscopic scissors, endoscopic knife blade handles, hooks and clip appliers, endoscopic irrigation probes, endoscopic electrodes, retractors and rib spreaders, thoraports and cannulas.
This document is a 510(k) summary for surgical instruments and does not contain information about acceptance criteria or a study proving device performance as might be found for a diagnostic or AI-driven device. It focuses on demonstrating substantial equivalence to previously cleared devices. Therefore, I cannot extract the requested information from this text.
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.