Cleared Traditional

AF/SYSTEM (K791192) - FDA 510(k) Clearance

K791192 · Ariel · General & Plastic Surgery device
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Sep 1979
Decision
86d
Days
-
Risk

K791192 is an FDA 510(k) clearance for the AF/SYSTEM.

Submitted by Ariel (Mchenry, US). The FDA issued a Cleared decision on September 20, 1979 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K791192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1979
Decision Date September 20, 1979
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -