Tornado Rotatabel Snare and Polyp Catcher

510(k) Number

K083049 ↗

FDA Product Code

FDI

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What types of polyps can the Tornado Rotatable Snare and Polyp Catcher be used to remove during endoscopic procedures?

  The Tornado Rotatable Snare and Polyp Catcher is specifically designed for capturing and removing polyps during gastrointestinal procedures. Its dual mechanism—combining a snare with a polyp catcher—allows for the retrieval of both single and multiple polyps in a single session, making it suitable for standard polypectomy tasks in the GI tract.

• Is the Tornado Rotatable Snare and Polyp Catcher reusable or intended for single-use, and how does this affect its sterility?

  The device is explicitly labeled for single-use only in endoscopic settings. Since it is supplied sterile, it must remain unopened and unused until the procedure begins, ensuring compliance with infection control protocols. Discarding after one use eliminates the need for reprocessing.

• What sizes or configurations are available for the Tornado Rotatable Snare and Polyp Catcher, and how do I identify them?

  The device comes in multiple sizes and configurations, each referenced by distinct product codes (e.g., 3006546082, 1037905, etc.). These codes correspond to variations in design or dimensions, allowing clinicians to select the appropriate size for their patient’s anatomy or procedural needs. The manufacturer’s documentation or packaging will list the exact product code for each unit.

• How should the Tornado Rotatable Snare and Polyp Catcher be stored before use, and what are the key handling instructions?

  Since the device is sterile, it must be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to preserve sterility. Always follow the manufacturer’s instructions for opening and handling to prevent contamination.

• Does the Tornado Rotatable Snare and Polyp Catcher require any specific equipment to operate, and how is it powered?

  The device requires connection to an electrosurgical unit for monopolar use during procedures. It is not battery-powered or standalone—its functionality depends on the electrosurgical generator to deliver energy for snaring and polyp removal. Ensure compatibility with your facility’s electrosurgical equipment before use.