CAUTERY TIP CLEANER, MODEL-TC-100

• K Number: K030339
• Device Name: CAUTERY TIP CLEANER, MODEL-TC-100
• Manufacturer: ASPEN SURGICAL PRODUCTS, INC.
• Date Cleared: 2003-03-07 ( 35 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The disposable Cautery Tip Cleaner is a single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electro surgical instruments during the course of a surgical procedure.

Device Description

Not Found

AI/ML Overview

This is a premarket notification for an Electro-Cautery Tip Cleaner, a device designed to remove eschar build-up from electrosurgical instruments. The FDA has determined it is substantially equivalent to legally marketed predicate devices. Unfortunately, the provided document does not contain any information regarding specific acceptance criteria, performance data, or a study report for this device.

Therefore, I cannot provide the detailed information requested regarding the acceptance criteria and the study proving the device meets them. The document focuses on the regulatory approval process and not on the performance testing of the device itself.

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.