Cleared Traditional

HEALICOLL (K040314) - FDA 510(k) Clearance

K040314 · Encoll Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
185d
Days
-
Risk

K040314 is an FDA 510(k) clearance for the HEALICOLL. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Encoll Corp. (Newark, US). The FDA issued a Cleared decision on August 12, 2004 after a review of 185 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 Encoll Corp. devices

Submission Details

510(k) Number K040314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2004
Decision Date August 12, 2004
Days to Decision 185 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 115d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -