Cleared Traditional

COLLATEK POWDER (K012990) - FDA 510(k) Clearance

K012990 · Biocore Medical Technologies, Inc. · General & Plastic Surgery device
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Oct 2001
Decision
48d
Days
-
Risk

K012990 is an FDA 510(k) clearance for the COLLATEK POWDER. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Biocore Medical Technologies, Inc. (Silver Spring, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 48 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 Biocore Medical Technologies, Inc. devices

Submission Details

510(k) Number K012990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date October 24, 2001
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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