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The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

The EndoRotor® Airway Microdebridement System is a powered resection tool consisting of a power Console with Foot Control, Specimen Trap with pre-loaded filter, and a singleuse Catheter with a cutting tool mounted on the distal end. The EndoRotor's flexible design allows it to be used within the working channel of flexible bronchoscopes in tortuous paths. The Console houses the control panel, drive motor, vacuum control valve, and peristaltic irrigation pump drive. The Catheter includes a debriding cutter and allows for aspiration from the resection site through the bronchoscope working channel to the Specimen Trap.

The EndoRotor® is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.

The EndoRotor®, with the design modifications and expanded indications for use described in the current 510(k) premarket notification, will continue to be marketed as the EndoRotor®. The new EndoRotor® will be referred to as the "modified EndoRotor" in this 510(k) Summary. The overall device description remains unchanged since initial FDA clearance. Both the predicate and modified EndoRotor® are powered resection tools consisting of a power console, foot control, specimen trap with pre-loaded filter, and a single-use resection catheter that is inserted into the working channel of a compatible endoscope. The design modifications to the EndoRotor® described in the current 510(k) premarket notification include enhancements to improve the ease of use of the console and catheter components as well as provide flexibility to the gastroenterologist.