Cleared Traditional

K833997 - CO-SET (FDA 510(k) Clearance)

K833997 · American Edwards Laboratories · General & Plastic Surgery device
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Apr 1984
Decision
148d
Days
-
Risk

K833997 is an FDA 510(k) clearance for the CO-SET.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 148 days - within the typical 510(k) review window.

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 K833997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date April 17, 1984
Days to Decision 148 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
34d slower than avg
Panel avg: 114d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -