Cleared Traditional

FLEXIBLE FIBEROPTIC ENDOSCOPE (K850393) - FDA 510(k) Clearance

K850393 · Microvasive · Gastroenterology & Urology device
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Jun 1985
Decision
123d
Days
-
Risk

K850393 is an FDA 510(k) clearance for the FLEXIBLE FIBEROPTIC ENDOSCOPE.

Submitted by Microvasive (Milford, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel. 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.

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Submission Details

510(k) Number K850393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date June 04, 1985
Days to Decision 123 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
7d faster than avg
Panel avg: 130d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -