Cleared Traditional

K902410 - MEDICAL PROCEDURE TRAY (FDA 510(k) Clearance)

K902410 · Sorex Medical · General & Plastic Surgery device
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Nov 1990
Decision
173d
Days
-
Risk

K902410 is an FDA 510(k) clearance for the MEDICAL PROCEDURE TRAY.

Submitted by Sorex Medical (Salt Lake City, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 173 days - an extended review cycle.

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

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Submission Details

510(k) Number K902410 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 31, 1990
Decision Date November 20, 1990
Days to Decision 173 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 114d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -