Cleared Traditional

MICRO-COLL COLLAGEN DERMAL WOUND SPRAY (K920642) - FDA 510(k) Clearance

K920642 · Micro-Collagen Pharmaceutics, Ltd. · General & Plastic Surgery device
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Apr 1992
Decision
77d
Days
-
Risk

K920642 is an FDA 510(k) clearance for the MICRO-COLL COLLAGEN DERMAL WOUND SPRAY. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Micro-Collagen Pharmaceutics, Ltd. (Bangor, US). The FDA issued a Cleared decision on April 29, 1992 after a review of 77 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 Micro-Collagen Pharmaceutics, Ltd. devices

Submission Details

510(k) Number K920642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1992
Decision Date April 29, 1992
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -