Cleared Traditional

THE GALASSIA SYSTEM (K791191) - FDA 510(k) Clearance

K791191 · Ariel · General Hospital
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Sep 1979
Decision
90d
Days
-
Risk

K791191 is an FDA 510(k) clearance for the THE GALASSIA SYSTEM.

Submitted by Ariel (Mchenry, US). The FDA issued a Cleared decision on September 24, 1979 after a review of 90 days - within the typical 510(k) review window.

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

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Submission Details

510(k) Number K791191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1979
Decision Date September 24, 1979
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -