Cleared Traditional

EXU-DRY BURN-TRAUMA DRESSING-VARIOUS (K840498) - FDA 510(k) Clearance

K840498 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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May 1984
Decision
114d
Days
-
Risk

K840498 is an FDA 510(k) clearance for the EXU-DRY BURN-TRAUMA DRESSING-VARIOUS.

Submitted by Fraass Survival Systems, Inc. (Walker, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 114 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.

View all Fraass Survival Systems, Inc. devices

Submission Details

510(k) Number K840498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date May 30, 1984
Days to Decision 114 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
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -