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The Olympus biopsy forceps are intended to be used for the collection of tissue samples under endoscopic observation.

The Olympus biopsy forceps are specifically designed for tissue collection within the respiratory organs. The FB series of biopsy forceps are substantially equivalent in intended use, method of operation, and safety to pre-Amendment and 510(k) cleared reusable biopsy forceps.

The provided text is a 510(k) summary for Olympus Biopsy Forceps. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

The 510(k) summary focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study as would be described for an AI/software as a medical device (SaMD).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets it, as this information is not present in the provided document.

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