Cleared Traditional

Logic Hd camera head green, System green

K212808 · Richard Wolf Medical Instruments Corporation · General & Plastic Surgery

Jun 2022

Decision

284d

Days

Class 2

Risk

About This 510(k) Submission

K212808 is an FDA 510(k) clearance for the Logic Hd camera head green, System green, a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on June 14, 2022, 284 days after receiving the submission on September 3, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K212808 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2021
Decision Date	June 14, 2022
Days to Decision	284 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	FET — Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.