Cleared Traditional

PROCEL BURN COVER/PROCEL BURN TREATMENT COVER (K943280) - FDA 510(k) Clearance

K943280 · W.L. Gore & Company, GmbH · General & Plastic Surgery device
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Aug 1994
Decision
42d
Days
-
Risk

K943280 is an FDA 510(k) clearance for the PROCEL BURN COVER/PROCEL BURN TREATMENT COVER. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by W.L. Gore & Company, GmbH (Putzbrunn, DE). The FDA issued a Cleared decision on August 18, 1994 after a review of 42 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.

View all W.L. Gore & Company, GmbH devices

Submission Details

510(k) Number K943280 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 07, 1994
Decision Date August 18, 1994
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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