Cleared Traditional

K840362 - COMFEEL PASTE (FDA 510(k) Clearance)

K840362 · Coloplast A/S · General & Plastic Surgery device
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Nov 1984
Decision
286d
Days
-
Risk

K840362 is an FDA 510(k) clearance for the COMFEEL PASTE.

Submitted by Coloplast A/S (Fort Worth, US). The FDA issued a Cleared decision on November 7, 1984 after a review of 286 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.

View all Coloplast A/S devices

Submission Details

510(k) Number K840362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date November 07, 1984
Days to Decision 286 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
172d slower than avg
Panel avg: 114d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -