Cleared Traditional

K863931 - CARBONET ODOUR ADSORBING DRESSING (FDA 510(k) Clearance)

K863931 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Dec 1986
Decision
54d
Days
-
Risk

K863931 is an FDA 510(k) clearance for the CARBONET ODOUR ADSORBING DRESSING.

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on December 1, 1986 after a review of 54 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K863931 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 08, 1986
Decision Date December 01, 1986
Days to Decision 54 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
60d faster than avg
Panel avg: 114d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -