FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Olympus basket graspers are designed to retrieving foreign body, excised tissue, etc., under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the grasping basket.

AI/ML Overview

This 510(k) summary for the Olympus FG Basket Grasping Forceps describes a medical device with a purely mechanical function (retrieving foreign bodies/excised tissue). The provided document does not contain information related to software-based AI/ML devices or studies proving performance based on metrics like sensitivity, specificity, or accuracy.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies demonstrating performance in the context of AI/ML, as none of that information is present in the provided text. The summary focuses on regulatory classification, intended use, and a basic mechanical description.

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K Number

K955063

Device Name

OLYMPUS BASKET GRASPERS

Manufacturer

OLYMPUS AMERICA, INC.

Date Cleared

1996-01-22

(77 days)

Product Code