Cleared Traditional

K915695 - PROCEL BURN COVER (FDA 510(k) Clearance)

K915695 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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May 1992
Decision
158d
Days
-
Risk

K915695 is an FDA 510(k) clearance for the PROCEL BURN COVER. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 158 days - an extended review 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: 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 K915695 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 23, 1991
Decision Date May 29, 1992
Days to Decision 158 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
44d slower than avg
Panel avg: 114d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -