Cleared Traditional

BIOBRANE BRAND TEMPORARY WOUND DRESSING (K791184) - FDA 510(k) Clearance

K791184 · Hall-Woodroof, Inc. · General & Plastic Surgery device
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Nov 1979
Decision
143d
Days
-
Risk

K791184 is an FDA 510(k) clearance for the BIOBRANE BRAND TEMPORARY WOUND DRESSING.

Submitted by Hall-Woodroof, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1979 after a review of 143 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 Hall-Woodroof, Inc. devices

Submission Details

510(k) Number K791184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date November 15, 1979
Days to Decision 143 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
28d slower than avg
Panel avg: 115d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -