MONOPOLAR ELECTRODES AND CABLES

• K Number: K992485
• Device Name: MONOPOLAR ELECTRODES AND CABLES
• Manufacturer: US ENDO, INC.
• Date Cleared: 1999-08-27 ( 32 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Monopolar Electrodes and Accessories are indicated when Endoscopy is indicated, used primarily to coagulate tissue, for use with HF Electrosurgical Units

Targeted Anatomical sites include primarily, the Abdominal (suprapubic) region.

The device is reusable, non-sterile, for use as follows:

1. Spatula tip-Dissection-Coagulation & manipulation of tissue.
2. L-Hook tip-Dissection & manipulation
3. J-Hook tip-Core out with a knife-cutting effect (ablation)
4. Knife-tip-Coagulate with scalpel-like cutting
5. Button/Needle-tip-Spot coagulation

Device Description

Monopolar Electrodes and Accessories

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for "Monopolar Electrodes and Cables" and the associated "Indications for Use Statement". It does not contain information about acceptance criteria, device performance, or any studies as requested. The device mentioned is a traditional medical instrument, not an AI/ML powered device, so many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, training set size) are not applicable.

Therefore, I cannot provide the requested information based on the given input.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.