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

FDA 510(k) Search

K Number

K002877

Device Name

MICTEC ENDOSCOPES AND ACCESSORIES

Manufacturer

DUFNER INSTRUMENTE GMBH

Date Cleared

2001-02-05

(143 days)

Product Code

GEI,GCJ,HET

Regulation Number

878.4400

Type

Abbreviated

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Summary

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.