Cleared Traditional

S-57 VIDEO IMAGING SYSTEM

K962024 · Del Medical Systems Corp. · Gastroenterology & Urology

Jul 1996

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K962024 is an FDA 510(k) clearance for the S-57 VIDEO IMAGING SYSTEM, a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Del Medical Systems Corp. (Valhalla, US). The FDA issued a Cleared decision on July 9, 1996, 47 days after receiving the submission on May 23, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K962024 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1996
Decision Date	July 09, 1996
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
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.