Cleared Traditional

K900894 - MEDILASE SERIES 2100 ENDOSCOPE

K900894 is an FDA 510(k) clearance for MEDILASE SERIES 2100 ENDOSCOPE, manufactured by Medical Laser, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCQ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K900894 · Medical Laser, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
115d
Days
Class 2
Risk

K900894 is an FDA 510(k) clearance for the MEDILASE SERIES 2100 ENDOSCOPE. Classified as Endoscope, Flexible (product code GCQ), Class II - Special Controls.

Submitted by Medical Laser, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 115 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 - K900894

510(k) Number K900894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date June 22, 1990
Days to Decision 115 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
15d faster than avg
Panel avg: 130d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCQ Device Classification - Class 2, Special Controls

Product Code GCQ Endoscope, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCQ Endoscope, Flexible

Devices cleared under the same product code (GCQ) and FDA review panel - the closest regulatory comparables to K900894.
CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)
K920979 · Codman & Shurtleff, Inc. · Mar 1993
CODMAN FLEXIBLE ENDOSCOPE
K871978 · Codman & Shurtleff, Inc. · Aug 1987
TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
K864960 · Cooper Lasersonics, Inc. · Feb 1987
VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE
K860771 · Van-Tec, Inc. · Apr 1986