Cleared Traditional

K832405 - OPTHALMIC ENDOSCOPE (FDA 510(k) Clearance)

K832405 · Cilco, Inc. · Neurology device
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Nov 1983
Decision
123d
Days
-
Risk

K832405 is an FDA 510(k) clearance for the OPTHALMIC ENDOSCOPE.

Submitted by Cilco, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cilco, Inc. devices

Submission Details

510(k) Number K832405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1983
Decision Date November 21, 1983
Days to Decision 123 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -