TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES

• K Number: K012725
• Device Name: TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
• Manufacturer: ENDO-THERAPEUTICS, INC.
• Date Cleared: 2001-11-08 ( 85 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K012525

Intended Use

The Endo-Therapeutics Laparoscopic Surgical Instruments are a line of reusable general surgical forceps, graspers and scissors intended to be used for lifting, dissecting, cutting organs and tissue during general open and laparoscopic procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets them. The document is an FDA 510(k) clearance letter for "Endo-Therapeutics Laparoscopic Instruments," indicating that the device has been found substantially equivalent to a predicate device. It specifies the product's intended use but does not detail any performance studies, acceptance criteria, or ground truth establishment. Therefore, I cannot extract the requested information.

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.