Cleared Traditional

K844774 - EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS

K844774 is an FDA 510(k) clearance for EFFNER FIBER OPTIC CABLES FOR COLD LIGH..., manufactured by Mecron Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCR cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K844774 · Mecron Medical Products, Inc. · Gastroenterology & Urology device
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Apr 1985
Decision
133d
Days
Class 2
Risk

K844774 is an FDA 510(k) clearance for the EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS. Classified as Light Source, Photographic, Fiberoptic (product code FCR), Class II - Special Controls.

Submitted by Mecron Medical Products, Inc. (Port Washington, US). The FDA issued a Cleared decision on April 22, 1985 after a review of 133 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 Mecron Medical Products, Inc. devices

FDA 510(k) Submission Details - K844774

510(k) Number K844774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date April 22, 1985
Days to Decision 133 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: 131d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCR Device Classification - Class 2, Special Controls

Product Code FCR Light Source, Photographic, Fiberoptic
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.