Search Results

Horizons Hot Biopsy Forceps is intended to be used in the flexible endescope for transendoscopic, dissecting, and grasping tissue for biopsy.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Horizons Hot Biopsy Forceps." It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested.

The letter explicitly states that the device is found to be "substantially equivalent" to legally marketed predicate devices, which means it doesn't require a new premarket approval application (PMA). This type of clearance generally relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. Formal clinical studies with acceptance criteria and detailed performance metrics are typically not required for 510(k) submissions unless specifically requested by the FDA due to unique concerns.

Therefore, I cannot fulfill your request using the provided input. The document does not contain the necessary information.

Ask a specific question about this device