WILTEK HOT BIOPSY FORCEPS

• K Number: K990231
• Device Name: WILTEK HOT BIOPSY FORCEPS
• Manufacturer: WILTEK MEDICAL, INC.
• Date Cleared: 1999-04-13 ( 78 days)
• Product Code: KGE
• Regulation Number: 876.4300
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Wiltek Hot Biopsy Forcep is intended for transendoscopic biopsy of the GI tract.

Device Description

Wiltek Hot Biopsy Forcep

AI/ML Overview

The provided documents are a 510(k) clearance letter and an Indications For Use statement for the Wiltek Hot Biopsy Forcep. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).