Cleared Traditional

K901464 - MEDILASE SERIES 2200 ENDOSCOPE

K901464 is an FDA 510(k) clearance for MEDILASE SERIES 2200 ENDOSCOPE, manufactured by Medical Laser, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCM cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K901464 · Medical Laser, Inc. · Gastroenterology & Urology device
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Aug 1990
Decision
132d
Days
Class 2
Risk

K901464 is an FDA 510(k) clearance for the MEDILASE SERIES 2200 ENDOSCOPE. Classified as Endoscope, Rigid (product code GCM), Class II - Special Controls.

Submitted by Medical Laser, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 7, 1990 after a review of 132 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 - K901464

510(k) Number K901464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1990
Decision Date August 07, 1990
Days to Decision 132 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
2d slower than avg
Panel avg: 130d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCM Device Classification - Class 2, Special Controls

Product Code GCM Endoscope, Rigid
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 - GCM Endoscope, Rigid

All 10
Devices cleared under the same product code (GCM) and FDA review panel - the closest regulatory comparables to K901464.
KARL STORZ PLASTIC SURGERY ACCESSORIES
K945889 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
THORACOSCOPE/LAPAROSCOPE
K931954 · Surgical Technologies, Inc. · Nov 1993
PRESSURE TURING AND ACCESSORIES
K925918 · Applied Medical Resources · Feb 1993
LAMANO DIRECTORS
K894592 · Marlo Surgical Technology · Sep 1989
RIGID ENDOSCOPE
K853514 · American Edwards Laboratories · Oct 1985