Cleared Traditional

K900380 - MEDILASE 5010 ENDOSCOPE CONSOLE

K900380 is an FDA 510(k) clearance for MEDILASE 5010 ENDOSCOPE CONSOLE, manufactured by Medical Laser, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K900380 · Medical Laser, Inc. · Gastroenterology & Urology device
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May 1990
Decision
109d
Days
Class 2
Risk

K900380 is an FDA 510(k) clearance for the MEDILASE 5010 ENDOSCOPE CONSOLE. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Medical Laser, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Laser, Inc. devices

FDA 510(k) Submission Details - K900380

510(k) Number K900380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1990
Decision Date May 15, 1990
Days to Decision 109 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 130d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 58
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K900380.
FUJINON VIDEO LAPAROSCOPE -- MODIFIED
K932312 · Fujinon, Inc. · Feb 1994
EPM-3300 VIDEO PROCESSOR
K934918 · Pentax Precision Instrument Corp. · Feb 1994
COLOR VIDEO CAMERA
K911485 · United States Endoscopy Group, Inc. · Aug 1991
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
K870680 · Medline Industries, Inc. · Apr 1987
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
K853585 · Olympus Corp. · Jan 1986
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
K843198 · Life-Tech Intl., Inc. · Oct 1984