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

Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.

Device Description

System 7500 Electrosurgical Unit

AI/ML Overview

This document is an FDA 510(k) clearance letter for the "System 7500 Electrosurgical Unit". It states that the device is substantially equivalent to legally marketed predicate devices for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.

However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, study details, sample sizes, ground truth establishment, or expert qualifications. The letter is purely regulatory in nature, indicating approval for marketing based on substantial equivalence.

Therefore, I cannot fulfill your request for the detailed table and study information.

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K Number

K963088

Device Name

SHEATH, ELECTROSURGICAL PENCIL

Manufacturer

ASPEN LABORATORIES, INC.

Date Cleared

1996-09-13

(36 days)