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The US Endoscopy EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract.

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The provided text is an FDA 510(k) clearance letter for the "EUS Balloon" device, along with its Indications for Use. This type of document does not contain acceptance criteria or a study description in the format requested.

The FDA 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for novel performance claims. Substantial equivalence is often shown through comparisons of technological characteristics and, if applicable, performance data to a predicate.

Therefore, I cannot extract the requested information from the provided text. The document states:

• Device Name: EUS Balloon
• Regulation Number: 21 CFR §876.1500 (Endoscope and accessories)
• Regulatory Class: II
• Product Code: FDF and ITX
• Indications for Use: "The US Endoscopy EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract."

To answer your questions, one would typically need access to the actual 510(k) submission document, which would contain the performance testing and comparisons made to demonstrate substantial equivalence.

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